New Drug Approvals Archive for 2008

Alvesco (ciclesonide) Inhalation Aerosol

Date of Approval: January 10, 2008
Company: Nycomed
Treatment for: Asthma

Alvesco (ciclesonide) is an inhaled corticosteroid indicated for the maintenance treatment of asthma and as prophylactic therapy in adult and adolescent patients aged 12 years and older.

• Alvesco Gains FDA Approval for the U.S. Market
• Alvesco (ciclesonide) FDA Approval History

Flo-Pred (prednisolone acetate) Oral Suspension

Date of Approval: January 17, 2008
Company: Taro Pharmaceutical Industries Ltd.
Treatment for: Asthma, Inflammatory Conditions

Marketing Status: Discontinued

Flo-Pred (prednisolone acetate) is a cherry flavored oral liquid corticosteroid formulation which does not require refrigeration and does not require shaking prior to use. Flo-Pred is an anti-inflammatory agent for the treatment of asthma, certain allergic and dermatologic conditions, as well as a variety of other indications.

• Taro Receives FDA Approval of New Drug Application for Flo-Pred (Prednisolone Acetate Oral Suspension)
• Flo-Pred (prednisolone acetate) FDA Approval History

Recothrom (Thrombin, topical (Recombinant)) - formerly rhThrombin

Date of Approval: January 17, 2008
Company: ZymoGenetics, Inc.
Treatment for: Hemostasis During Surgery

Recothrom is a recombinant form of human thrombin indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical. Recothrom may be used in conjunction with an absorbable gelatin sponge, USP.

• FDA Approves ZymoGenetics' Recothrom Thrombin, topical(Recombinant)
• Recothrom (Thrombin, topical (Recombinant)) FDA Approval History

Intelence (etravirine) Tablets - formerly TMC125

Date of Approval: January 18, 2008
Company: Tibotec Pharmaceuticals Ltd.
Treatment for: HIV Infection

Intelence (etravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

• FDA Approves Intelence (etravirine) for HIV Combination Therapy
• Intelence (etravirine) FDA Approval History

Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets

Date of Approval: January 18, 2008
Company: Novartis Pharmaceuticals Corporation
Treatment for: High Blood Pressure

Tekturna HCT (aliskiren and hydrochlorothiazide) is a single-tablet combination therapy for the treatment of high blood pressure.

• Tekturna HCT, a Single-Tablet Combination of Tekturna and a Diuretic, Receives US Approval for Treatment of High Blood Pressure
• Tekturna HCT (aliskiren and hydrochlorothiazide) FDA Approval History

Moxatag (amoxicillin) Extended Release Tablets

Date of Approval: January 23, 2008
Company: Pragma
Treatment for: Tonsillitis/Pharyngitis

Marketing Status: Discontinued

Moxatag is a once-daily extended-release formulation of the penicillin antibiotic amoxicillin indicated for the treatment of adults and pediatric patients 12 years and older with pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes (commonly referred to as strep throat).

• FDA Approves MiddleBrook's Moxatag - Amoxicillin PULSYS - for Pharyngitis/Tonsillitis in Adolescents and Adults
• Moxatag (amoxicillin) FDA Approval History

Accretropin (somatropin (rDNA origin)) Subcutaneous Injection

Date of Approval: January 23, 2008
Company: Emergent
Treatment for: Pediatric Growth Hormone Deficiency, Turner Syndrome

Marketing Status: Discontinued

Accretropin (somatropin (rDNA origin)) is recombinant human growth hormone indicated for treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone, or treatment of short stature associated with Turner Syndrome in pediatric patients whose epiphyses are not closed.

• Cangene's Recombinant Human Growth Hormone Accretropin Approved by the U.S. Food and Drug Administration
• Accretropin (somatropin (rDNA origin)) FDA Approval History

Simcor (niacin ER and simvastatin) Tablets

Date of Approval: February 15, 2008
Company: Abbott
Treatment for: High Cholesterol

Simcor (niacin extended-release/simvastatin) is a fixed-dose combination lipid therapy used along with diet to lower levels of total cholesterol, LDL "bad" cholesterol and triglycerides, and to increase HDL "good" cholesterol.

• Abbott Receives FDA Approval for Simcor (Niaspan / simvastatin), a Novel Combination Medicine for Comprehensive Cholesterol Management
• Simcor (niacin ER and simvastatin) FDA Approval History

Xyntha (antihemophilic factor (recombinant), plasma/albumin free )

Date of Approval: February 21, 2008
Company: Wyeth Pharmaceuticals Inc.
Treatment for: Hemophilia A

Xyntha (Antihemophilic Factor (Recombinant) Plasma/Albumin Free) is a genetically engineered version of factor VIII, a protein essential for the clotting of blood. Xyntha is indicated for the control and prevention of bleeding episodes and for surgical prophylaxis in patients with hemophilia A.

• FDA Licenses Xyntha, a New Hemophilia Treatment
• Xyntha (antihemophilic factor (recombinant), plasma/albumin free ) FDA Approval History

Arcalyst (rilonacept) Injection - formerly Interleukin-1 Trap

Date of Approval: February 27, 2008
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Cryopyrin-Associated Periodic Syndromes; Deficiency of Interleukin-1 Receptor Antagonist; Recurrent Pericarditis

Arcalyst (rilonacept) is an interleukin-1 inhibitor indicated for the:

• treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS), and Muckle-Wells Syndrome (MWS) in adults and children 12 years and older
• maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing 10 kg or more
• treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and children 12 years and older.

• FDA Approves Arcalyst - New Orphan Drug for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
• Arcalyst (rilonacept) FDA Approval History

Pristiq (desvenlafaxine) Extended-Release Tablets

Date of Approval: February 29, 2008
Company: Wyeth Pharmaceuticals
Treatment for: Depression

Pristiq (desvenlafaxine) is a serotonin-norepinephrine reuptake inhibitor (SNRI) approved for the treatment for adult patients with major depressive disorder. Pristiq is also currently under review as a treatment for moderate-to-severe vasomotor symptoms associated with menopause.

• FDA Approves Pristiq for the Treatment of Adult Patients with MajorDepressive Disorder
• Pristiq (desvenlafaxine) FDA Approval History

Fusilev (levoleucovorin) for Injection

Date of Approval: March 7, 2008
Company: Spectrum Pharmaceuticals, Inc.
Treatment for: Methotrexate Rescue, Folic Acid Antagonist Overdose, Colorectal Cancer

Fusilev (levoleucovorin calcium) is a folate analog indicated for rescue after high-dose methotrexate therapy in osteosarcoma, diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists, and for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.

• FDA Approves New Drug Application for Levoleucovorin, Spectrum's First Proprietary Oncology Drug
• Fusilev (levoleucovorin) FDA Approval History

Artiss (fibrin sealant (human)) Topical Solution

Date of Approval: March 19, 2008
Company: Baxter Healthcare Corporation
Treatment for: Burns, External

Artiss (fibrin sealant (human)) is a slow-setting fibrin sealant indicated for use in adhering skin grafts in adult and pediatric burn patients and for tissue adherence in facial rhytidectomy (face-lift) surgery.

• FDA Approves Artiss Medical Adhesive to Treat Burn Patients
• Artiss (fibrin sealant (human)) FDA Approval History

Treanda (bendamustine hydrochloride) Injection

Date of Approval: March 20, 2008
Company: Cephalon, Inc.
Treatment for: Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma

Treanda (bendamustine) is a purine alkylator hybrid chemotherapy agent indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) and relapsed indolent non-Hodgkin's lymphoma.

• Cephalon Receives FDA Approval for Treanda, a Novel Chemotherapyfor Chronic Lymphocytic Leukemia
• Treanda (bendamustine hydrochloride) FDA Approval History

Rotarix (rotavirus vaccine, live attenuated) Oral Suspension

Date of Approval: April 3, 2008
Company: GlaxoSmithKline
Treatment for: Prevention of Rotavirus Gastroenteritis

Rotarix (rotavirus vaccine live) is an oral, two-dose, live attenuated vaccine for the prevention of rotavirus gastroenteritis in children.

• FDA Approves Rotarix Vaccine to Prevent Gastroenteritis Caused by Rotavirus
• Rotarix (rotavirus vaccine, live attenuated) FDA Approval History

Lexiscan (regadenoson) Injection

Date of Approval: April 10, 2008
Company: Astellas Pharma US, Inc.
Treatment for: Diagnosis and Investigation

Lexiscan (regadenoson) is an A2A adenosine receptor agonist indicated for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging (MPI), a test that detects and characterizes coronary artery disease, in patients unable to undergo adequate exercise stress.

• CV Therapeutics and Astellas Announce FDA Approval for Lexiscan(regadenoson) Injection
• Lexiscan (regadenoson) FDA Approval History

Treximet (sumatriptan succinate and naproxen sodium) Tablets - formerly Trexima

Date of Approval: April 15, 2008
Company: Pernix Therapeutics Holdings, Inc.
Treatment for: Migraine

Treximet is a combination of sumatriptan (a migraine-specific triptan) and naproxen (an anti-inflammatory pain reliever) in a single tablet for the acute treatment of migraine.

• Treximet (sumatriptan and naproxen sodium) Tablets Approved by FDAfor Acute Treatment of Migraine
• Treximet (sumatriptan succinate and naproxen sodium) FDA Approval History

Patanase (olopatadine hydrochloride) Nasal Spray

Date of Approval: April 15, 2008
Company: Alcon, Inc.
Treatment for: Allergic Rhinitis

Patanase (olopatadine) is an antihistamine nasal spray for the treatment of symptoms of seasonal allergic rhinitis in adults and adolescents twelve years of age and older.

• Alcon's Patanase Nasal Spray Approved by FDA for Treatment of Nasal Allergy Symptoms
• Patanase (olopatadine hydrochloride) FDA Approval History

Cimzia (certolizumab pegol) Injection

Date of Approval: April 22, 2008
Company: UCB, Inc.
Treatment for: Crohn's Disease, Active, Rheumatoid Arthritis, Psoriatic Arthritis, Plaque Psoriasis, Ankylosing Spondylitis

Cimzia (certolizumab) is a PEGylated anti-TNF (tumor necrosis factor) biologic therapy for the treatment of Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and non-radiographic axial spondyloarthritis.

• Cimzia Approved in the US for the Treatment of Moderate to Severe Crohn's Disease
• Cimzia (certolizumab pegol) FDA Approval History

Aplenzin (bupropion hydrobromide) Extended-Release Tablets - formerly BVF-033

Date of Approval: April 23, 2008
Company: Biovail Corporation
Treatment for: Depression

Aplenzin is a once-daily formulation of bupropion hydrobromide indicated for the treatment of depression in adults.

• Biovail Receives FDA Approval for Aplenzin (BVF-033)
• Aplenzin (bupropion hydrobromide) FDA Approval History

Relistor (methylnaltrexone bromide) Tablets and Subcutaneous Injection

Date of Approval: April 25, 2008
Company: Salix Pharmaceuticals, Inc.
Treatment for: Constipation

Relistor (methylnaltrexone) is a peripherally acting mu-opioid receptor antagonist indicated to treat opioid-induced constipation.

• Progenics and Wyeth Announce FDA Has Approved Relistor
• Relistor (methylnaltrexone bromide) FDA Approval History

OraVerse (phentolamine mesylate) Injection

Date of Approval: May 9, 2008
Company: Novalar Pharmaceuticals, Inc.
Treatment for: Reversal of Anesthesia

OraVerse is a dental anesthetic reversal agent that accelerates the return to normal sensation and function following dental procedures.

• Novalar Pharmaceuticals, Inc. Receives FDA Approval for OraVerse
• OraVerse (phentolamine mesylate) FDA Approval History

Entereg (alvimopan) Capsules

Date of Approval: May 20, 2008
Company: Merck
Treatment for: Postoperative Ileus

Entereg (alvimopan) is a peripherally-acting mu opioid receptor antagonist used to help patients regain gastrointestinal (GI) function earlier following bowel resection surgery.

• Adolor and GlaxoSmithKline Announce FDA Approval of Entereg (alvimopan) for the Management of Postoperative Ileus (POI)
• Entereg (alvimopan) FDA Approval History

Trivaris (triamcinolone acetonide) Intravitreal Injection

Date of Approval: June 16, 2008
Company: Allergan, Inc.
Treatment for: Ocular Inflammatory Conditions

Marketing Status: Discontinued

Trivaris (triamcinolone acetonide) is a glucocorticoid corticosteroid delivered via intravitreal injection for the treatment of sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.

• Allergan Receives U.S. Food and Drug Administration Approval for Trivaris (triamcinolone acetonide injectable suspension) 80 mg/mL
• Trivaris (triamcinolone acetonide) FDA Approval History

Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine)

Date of Approval: June 20, 2008
Company: Sanofi pasteur
Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Pertussis Prophylaxis, Poliomyelitis Prophylaxis, Haemophilus influenzae Prophylaxis

Pentacel is a combination vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b in children 6 weeks through 4 years of age.

• U.S. FDA Licenses Sanofi Pasteur's New Pediatric CombinationVaccine, Pentacel
• Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine) FDA Approval History

PrandiMet (repaglinide and metformin) Tablets

Date of Approval: June 23, 2008
Company: Sciele Pharma, Inc. and Novo Nordisk Inc.
Treatment for: Diabetes, Type 2

Marketing Status: Discontinued

PrandiMet (repaglinide and metformin HCl) is a fixed-dose combination of the fast-acting secretagogue replaglinide (also known as Prandin) and insulin sensitizer, metformin, indicated for the treatment of type 2 diabetes.

• FDA Approves PrandiMet, a Replaglinide and Metformin Fixed-Dose Combination Tablet for Treatment of Type 2 Diabetes
• PrandiMet (repaglinide and metformin) FDA Approval History

Durezol (difluprednate) Ophthalmic Emulsion

Date of Approval: June 23, 2008
Company: Sirion Therapeutics, Inc.
Treatment for: Postoperative Ocular Inflammation

Durezol (difluprednate ophthalmic emulsion) is a topical steroid for the treatment of postoperative ocular inflammation and pain.

• Sirion Therapeutics Announces FDA Approval of Durezol for Treatmentof Postoperative Ocular Inflammation and Pain
• Durezol (difluprednate) FDA Approval History

Kinrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)

Date of Approval: June 24, 2008
Company: GlaxoSmithKline
Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Poliomyelitis Prophylaxis, Pertussis Prophylaxis

Kinrix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine] is a combination vaccine for protection against diphtheria, tetanus, pertussis and polio diseases in children.

• FDA Approves Kinrix - New Combination Vaccine for Children
• Kinrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) FDA Approval History

Evolence (dermal filler)

Date of Approval: June 27, 2008
Company: OrthoNeutrogena
Treatment for: Facial Wrinkles

Evolence is a collagen-based structural dermal filler for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds.

• FDA Approves Evolence, a New Generation Collagen-Based Facial Filler
• Evolence (dermal filler) FDA Approval History

Eovist (gadoxetate disodium)

Date of Approval: July 3, 2008
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Diagnosis and Investigation

Eovist (gadoxetate disodium) is a gadolinium-based contrast agent for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease.

• FDA Approves Eovist to Detect and Characterize Focal Liver Lesions
• Eovist (gadoxetate disodium) FDA Approval History

Navstel (balanced salt ophthalmic solution with hypromellose, dextrose and glutathione) Intraocular Irrigating Solution

Date of Approval: July 24, 2008
Company: Alcon Laboratories, Inc.
Treatment for: Intraocular Irrigation

Marketing Status: Discontinued

Navstel is a balanced salt ophthalmic solution for use as an intraocular irrigation during surgical procedures involving perfusion of the eye.

• FDA Approves Navstel Intraocular Irrigating Solution
• Navstel (balanced salt ophthalmic solution with hypromellose, dextrose and glutathione) FDA Approval History

Stavzor (valproic acid) Capsules

Date of Approval: July 29, 2008
Company: Noven Pharmaceuticals, Inc.
Treatment for: Bipolar Disorder, Seizures, Epilepsy, Migraine Prevention

Marketing Status: Discontinued

Stavzor is delayed-release valproic acid formulated in the EnteriCare enteric soft gelatin capsule delivery system designed to minimize GI adverse events. Stavzor is indicated for the treatment of manic episodes associated with bipolar disorder, adjunctive therapy in multiple seizure types (including epilepsy), and prophylaxis of migraine headaches.

• Noven Announces Final FDA Approval of Stavzor for the Treatment of Bipolar Disorder, Seizures and Migraine Headaches
• Stavzor (valproic acid) FDA Approval History

Cleviprex (clevidipine butyrate) Injectable Emulsion

Date of Approval: August 1, 2008
Company: The Medicines Company
Treatment for: High Blood Pressure

Cleviprex (clevidipine) is an intravenous, ultrashort-acting calcium channel blocker under development for the treatment of severely elevated blood pressure in the hospital setting when oral therapy is not feasible or desirable.

• The Medicines Company’s Cleviprex Receives FDA Approval
• Cleviprex (clevidipine butyrate) FDA Approval History

Xenazine (tetrabenazine)

Date of Approval: August 15, 2008
Company: Prestwick Pharmaceuticals, Inc.
Treatment for: Huntington’s Chorea

Xenazine (tetrabenazine) is a selective and reversible centrally-acting dopamine depleting drug indicated for the treatment of chorea associated with Huntington's disease.

• Xenazine (Tetrabenazine) Approved by FDA for Patients with Chorea Associated with Huntington's Disease
• Xenazine (tetrabenazine) FDA Approval History

Nplate (romiplostim)

Date of Approval: August 22, 2008
Company: Amgen Inc.
Treatment for: Immune Thrombocytopenia

Nplate (romiplostim) is a thrombopoietin mimetic peptibody for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).

• FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP
• Nplate (romiplostim) FDA Approval History

Sancuso (granisetron) Transdermal Patch

Date of Approval: September 12, 2008
Company: ProStrakan Group plc
Treatment for: Nausea/Vomiting, Chemotherapy Induced

Sancuso (granisetron transdermal system) is an anti-emetic transdermal delivery system indicated for the control of nausea and vomiting in patients receiving moderately and/or highly nausea-inducing chemotherapy.

• FDA Approves Sancuso, the First and Only Patch for Preventing Nausea and Vomiting in Cancer Patients Undergoing Chemotherapy
• Sancuso (granisetron) FDA Approval History

AdreView (iobenguane I 123) Injection

Date of Approval: September 19, 2008
Company: GE Healthcare
Treatment for: Diagnosis and Investigation

AdreView is a diagnostic radiopharmaceutical agent indicated for use in the detection of rare neuroendocrine tumors in children and adults.

• FDA Approves GE Healthcare's AdreView (Iobenguane I 123 Injection) Diagnostic Agent for Detecting Neuroendocrine Tumors in Children, Adults
• AdreView (iobenguane I 123) FDA Approval History

Akten (lidocaine hydrochloride) Ophthalmic Gel

Date of Approval: October 7, 2008
Company: Akorn, Inc.
Treatment for: Ocular Anesthesia

Akten (lidocaine hydrochloride) Ophthalmic Gel is a topical, ocular anesthetic formulation for use in ocular procedures that require a topical anesthetic agent.

• Akorn, Inc. Announces the FDA Approval of Akten Ophthalmic Gel 3.5%
• Akten (lidocaine hydrochloride) FDA Approval History

Rapaflo (silodosin) Capsules

Date of Approval: October 8, 2008
Company: AbbVie Inc.
Treatment for: Benign Prostatic Hyperplasia

Rapaflo (silodosin) is an alpha(1)- adrenoreceptor antagonist for the treatment of the signs and symptoms associated with benign prostatic hyperplasia (BPH), or enlarged prostate.

• Watson Receives US FDA Approval for Rapaflo (silodosin) for the Treatment of Benign Prostatic Hyperplasia (BPH)
• Rapaflo (silodosin) FDA Approval History

Cinryze (C1 esterase inhibitor (human)) Injection

Date of Approval: October 10, 2008
Company: Shire plc
Treatment for: Hereditary Angioedema

Cinryze is a C1-esterase inhibitor indicated for routine prophylaxis against angioedema attacks in patients with hereditary angioedema (HAE).

• Cinryze Receives FDA Approval for Prophylaxis Against Hereditary Angioedema Attacks
• Cinryze (C1 esterase inhibitor (human)) FDA Approval History

Acanya (benzoyl peroxide and clindamycin phosphate) Topical Gel

Date of Approval: October 21, 2008
Company: Dow Pharmaceutical Sciences, Inc.
Treatment for: Acne

Acanya (benzoyl peroxide and clindamycin phosphate) is a topical antibacterial and antibiotic combination for the treatment of acne.

• FDA Approves Acanya
• Acanya (benzoyl peroxide and clindamycin phosphate) FDA Approval History

LoSeasonique (ethinyl estradiol and levonorgestrel) Extended-Cycle Oral Contraceptive Tablets

Date of Approval: October 24, 2008
Company: Duramed Pharmaceuticals, Inc.
Treatment for: Birth Control

LoSeasonique is a lower-dose, extended-cycle oral contraceptive indicated for the prevention of pregnancy.

• FDA Approves Duramed's LoSeasonique Oral Contraceptive
• LoSeasonique (ethinyl estradiol and levonorgestrel) FDA Approval History

Vimpat (lacosamide) Tablets, Injection, Oral Solution

Date of Approval: October 28, 2008
Company: UCB
Treatment for: Seizures

Vimpat (lacosamide) is an anti-convulsant indicated for the treatment of partial-onset seizures in patients 1 month of age and older, and the adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.

• UCB's Vimpat Approved By U.S. FDA As Adjunctive Therapy for Partial Onset Seizures in Adults
• Vimpat (lacosamide) FDA Approval History

Toviaz (fesoterodine fumarate) Extended Release Tablets

Date of Approval: October 31, 2008
Company: Pfizer Inc.
Treatment for: Urinary Frequency

Toviaz (fesoterodine fumarate) is a competitive muscarinic receptor antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

• Pfizer's Toviaz (fesoterodine fumarate) Receives FDA Approval for the Treatment of Overactive Bladder
• Toviaz (fesoterodine fumarate) FDA Approval History

Apriso (mesalamine) Extended-Release Capsules

Date of Approval: October 31, 2008
Company: Salix Pharmaceuticals, Ltd.
Treatment for: Ulcerative Colitis

Apriso (mesalamine) is a once-daily, locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis (UC) in adults.

• Apriso Granted FDA Marketing Approval for Maintenance of Remission of Ulcerative Colitis
• Apriso (mesalamine) FDA Approval History

Banzel (rufinamide)

Date of Approval: November 14, 2008
Company: Eisai Medical Research Inc.
Treatment for: Lennox-Gastaut Syndrome

Banzel (rufinamide) is a triazole derivative antiepileptic drug for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome.

• FDA Approves Banzel (rufinamide) as Adjunctive Treatment for Severe Epilepsy Disorder
• Banzel (rufinamide) FDA Approval History

Promacta (eltrombopag) Tablets

Date of Approval: November 20, 2008
Company: Novartis Pharmaceuticals Corporation
Treatment for: Immune Thrombocytopenia, Thrombocytopenia, Aplastic Anemia

Promacta (eltrombopag) is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura, thrombocytopenia in patients with chronic hepatitis C, and patients with severe aplastic anemia.

• FDA Approves Promacta (eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorder
• Promacta (eltrombopag) FDA Approval History

Nucynta (tapentadol) Tablets

Date of Approval: November 20, 2008
Company: Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Treatment for: Pain

Nucynta (tapentadol) is a centrally acting oral analgesic indicated for the relief of moderate to severe acute pain.

• FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe Acute Pain
• Nucynta (tapentadol) FDA Approval History

SCE-A (Synthetic Conjugated Estrogens-A) Vaginal Cream

Date of Approval: November 28, 2008
Company: Duramed Pharmaceuticals, Inc.
Treatment for: Postmenopausal Symptoms

Marketing Status: Discontinued

SCE-A (synthetic conjugated estrogens, A) Vaginal Cream is a plant-derived local estrogen product indicated for the treatment of moderate to severe vaginal dryness and pain with intercourse, both of which are symptoms of vulvar and vaginal atrophy due to menopause.

• FDA Approves Duramed's Synthetic Conjugated Estrogens-A Vaginal Cream
• SCE-A (Synthetic Conjugated Estrogens-A) FDA Approval History

Lusedra (fospropofol disodium) Injection

Date of Approval: December 12, 2008
Company: Eisai Corporation of North America
Treatment for: Sedation

Marketing Status: Discontinued

Lusedra (fospropofol disodium) is an intravenous sedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.

• FDA Approves Lusedra (fospropofol disodium) Injection for Monitored Anesthesia Care (MAC) Sedation
• Lusedra (fospropofol disodium) FDA Approval History

Trilipix (fenofibric acid) Delayed-Release Capsules

Date of Approval: December 15, 2008
Company: AbbVie Inc.
Treatment for: Hypertriglyceridemia, High Cholesterol

Trilipix (fenofibric acid) is a peroxisome proliferator receptor alpha (PPARα) activator indicated for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. Trilipix is the first and only fibrate to be approved for use in combination with a statin.

• Abbott Receives FDA Approval for Trilipix (fenofibric acid), First and Only Fibrate Indicated for Use in Combination With a Statin for Cholesterol Management
• Trilipix (fenofibric acid) FDA Approval History

Mozobil (plerixafor)

Date of Approval: December 15, 2008
Company: Genzyme Corporation
Treatment for: Bone Marrow Transplantation

Mozobil (plerixafor) is a small molecule CXCR4 chemokine receptor antagonist used in combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma.

• FDA Approves Genzyme's Mozobil
• Mozobil (plerixafor) FDA Approval History

Oforta (fludarabine phosphate) Tablets

Date of Approval: December 18, 2008
Company: sanofi-aventis U.S.
Treatment for: Chronic Lymphocytic Leukemia

Marketing Status: Discontinued

Oforta (fludarabine phosphate) is an oral nucleoside analogue approved as a single agent for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL).

• Antisoma Receives FDA Approval for Oral Fludarabine, Plans Commercialization Deal to Bring Drug to US Patients
• Oforta (fludarabine phosphate) FDA Approval History

Zolpimist (zolpidem tartrate) Oral Spray

Date of Approval: December 19, 2008
Company: NovaDel Pharma, Inc.
Treatment for: Insomnia

Zolpimist is an oral spray formulation of zolpidem, the drug contained in Ambien. Zolpimist is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

• NovaDel Pharma Receives FDA Approval of Zolpimist
• Zolpimist (zolpidem tartrate) FDA Approval History

Ablavar (gadofosveset trisodium) - formerly Vasovist

Date of Approval: December 22, 2008
Company: EPIX Pharmaceuticals, Inc.
Treatment for: Diagnosis and Investigation

Marketing Status: Discontinued

Ablavar (gadofosveset trisodium) is a blood pool magnetic resonance angiography (MRA) agent used to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.

• EPIX Pharmaceuticals Announces FDA Approval of Vasovist (gadofosveset trisodium)
• Ablavar (gadofosveset trisodium) FDA Approval History

Firmagon (degarelix) for Injection

Date of Approval: December 24, 2008
Company: Ferring Pharmaceuticals, USA
Treatment for: Prostate Cancer

Firmagon (degarelix) is an injectable gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for patients with advanced prostate cancer.

• FDA Approves Ferring Pharmaceuticals' Degarelix for Treatment of Advanced Prostate Cancer
• Firmagon (degarelix) FDA Approval History

Latisse (bimatoprost) Ophthalmic Solution

Date of Approval: December 24, 2008
Company: AbbVie Inc.
Treatment for: Hypotrichosis of Eyelashes

Latisse (bimatoprost ophthalmic) is a prostamide indicated for the treatment of hypotrichosis (or reduced amount of hair) of the eyelashes. Growth of the eyelashes is a well documented side effect of bimatoprost which is currently approved as Lumigan for the treatment of glaucoma.

• Allergan Announces U.S. Food and Drug Administration (FDA) Approval of Latisse -- First and Only Treatment Approved by the FDA for Hypotrichosis of Eyelashes
• Latisse (bimatoprost) FDA Approval History

Ryzolt (tramadol) Extended Release Tablets

Date of Approval: December 30, 2008
Company: Labopharm Inc.
Treatment for: Pain

Marketing Status: Discontinued

Ryzolt (tramadol extended release) is a once-daily analgesic indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

• Labopharm Announces FDA Approval of Once-Daily Ryzolt for Moderate to Moderately Severe Chronic Pain
• Ryzolt (tramadol) FDA Approval History

Nexterone (amiodarone HCl) Injection

Date of Approval: December 24, 2008
Company: Prism Pharmaceuticals
Treatment for: Ventricular Fibrillation, Ventricular Tachycardia

Nexterone (amiodarone HCl) Injection is a cosolvent free formulation of the antiarrhythmic agent Amiodarone IV, originally marketed in the US by Wyeth as Cordarone Intravenous. Nexterone is indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

• Prism Pharmaceuticals Receives FDA Approval of Nexterone for Life-Threatening Ventricular Fibrillation and Ventricular Tachycardia
• Nexterone (amiodarone HCl) FDA Approval History

Epiduo (adapalene and benzoyl peroxide) Gel

Date of Approval: December 8, 2008
Company: Galderma Laboratories, L.P.
Treatment for: Acne

Epiduo (adapalene and benzoyl peroxide) Gel is a once-daily, topical retinoid and antimicrobial combination for the treatment of acne.

• Galderma Announces Availability Of Epiduo Gel, The First And Only Combination Treatment With A Retinoid And Benzoyl Peroxide To Treat Acne
• Epiduo (adapalene and benzoyl peroxide) FDA Approval History