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Pain News (Page 6)
Zogenix Receives FDA Approval for New Abuse-Deterrent Formulation of Zohydro ER
SAN DIEGO, Jan. 30, 2015 – Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of central nervous system (CNS) disorders, today announced...
FDA Medwatch Alert: Prescription and Over-the-Counter (OTC) Pain Medicines: Drug Safety Communication - FDA Review of Possible Risks of Pain Medicine Use During Pregnancy
[Posted 01/09/2015] ISSUE: FDA is aware of and understands the concerns arising from recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used ...
Hospira Receives U.S. FDA Approval of Proprietary Analgesic Dyloject (diclofenac sodium) Injection
LAKE FOREST, Ill., Dec. 30, 2014 /PRNewswire/ – Hospira, Inc. (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, has...
FDA Approves Hysingla ER - Extended-Release Hydrocodone with Abuse-Deterrent Properties
November 20, 2014 – The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily,...
FDA Medwatch Alert: Assured Brand Naproxen Sodium Tablets by Contract Packaging Resources, Inc.: Recall - Packaging Mix-Up
ISSUE: Contract Packaging Resources, a drug repackaging company, is voluntarily recalling 11,640 boxes of Assured brand Naproxen Sodium tablets because some cartons actually contain bottles of...
FDA Approves Labeling with Abuse-Deterrent Features for Embeda (morphine/naltrexone)
October 17, 2014 – The U.S. Food and Drug Administration today approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, an opioid analgesic to...
FDA Medwatch Alert: Ketorolac Tromethamine Injection, USP, 30mg/ml by Sagent Pharmaceuticals: Recall - Incorrect Labeling
ISSUE: Sagent Pharmaceuticals, Inc. issued a voluntary nationwide recall of three lots (lot numbers: MP5021, MP5024 and MP5025) of Ketorolac Tromethamine Injection, USP, 30mg/mL single-dose vials...
Iroko Pharmaceuticals Gains FDA Approval of Zorvolex for Management of Osteoarthritis Pain
PHILADELPHIA, August 25, 2014 — Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced today the United States Food and Drug A...
FDA Approves Targiniq ER Extended-Release Oxycodone with Abuse-Deterrent Properties
July 23, 2014 – Today, the U.S. Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting...
FDA Medwatch Alert: Epidural Corticosteroid Injection: Drug Safety Communication - Risk of Rare But Serious Neurologic Problems
Including methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone [Posted 04/23/2014] ISSUE: FDA is warning that injection of corticosteroids into the epidural space of...
FDA Approves Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII)
DUBLIN--(BUSINESS WIRE)--Mar. 12, 2014-- Mallinckrodt plc today announced that the U.S. Food and Drug Administration (FDA) has approved Xartemis XR (oxycodone hydrochloride and acetaminophen)...
Iroko Pharmaceuticals Receives FDA Approval for Tivorbex
PHILADELPHIA, FEBRUARY 24, 2014 — Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that the U.S. Food and Drug A...
FDA Medwatch Alert: Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement - Recommendation to Discontinue Prescribing and Dispensing
ISSUE: FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per...
FDA Approves Zohydro ER, an Extended-Release, Single-Entity Hydrocodone Product
October 25, 2013 – The U.S. Food and Drug Administration today approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for the management of pain severe enough to require daily,...
Iroko Pharmaceuticals Receives FDA Approval for Zorvolex
Philadelphia, Pennsylvania, October 18, 2013 - Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that the U.S....
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