Skip to main content

Camcevi FDA Approval History

Last updated by Judith Stewart, BPharm on June 2, 2021.

FDA Approved: Yes (First approved May 26, 2021)
Brand name: Camcevi
Generic name: leuprolide mesylate
Dosage form: Injection
Company: Foresee Pharmaceuticals
Treatment for: Prostate Cancer

Camcevi (leuprolide mesylate) is a ready-to-use, 6-month depot formulation of the approved gonadotropin releasing hormone (GnRH) agonist leuprolide indicated for the treatment of adult patients with advanced prostate cancer.

Development timeline for Camcevi

DateArticle
Apr  2, 2024Positive Recommendation to Continue Phase 3 Clinical Trial of Leuprolide Injectable Emulsion for the Treatment of Central Precocious Puberty
May 26, 2021Approval FDA Approves Camcevi (leuprolide mesylate) for the Treatment of Advanced Prostate Cancer
Oct  9, 2020Foresee Pharmaceuticals Announces NDA for Camcevi™ 42mg Accepted for Review by the FDA
Jul 27, 2020Foresee Pharmaceuticals Announces Submission of NDA for FDA Approval of LMIS 50 mg
Mar 29, 2019Foresee Pharmaceuticals Announces Submission of NDA for FDA Approval of LMIS 50 mg

See also

Camcevi (leuprolide mesylate) Consumer information

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer