leuprolide mesylate 21 mg 3-month formulation (Camcevi): FDA status

No recent update Indication: advanced prostate cancer. Company: Foresee Pharmaceuticals.

Regulatory history

• Jan 13, 2025: FDA accepted for review. FDA accepted a new drug application for a 3 month formulation of leuprolide mesylate long acting injectable for advanced prostate cancer urologytimes.com
• Jan 13, 2025: Application filed. FDA accepted new drug application for a 3 month formulation of leuprolide mesylate (Camcevi 21 mg) for advanced prostate cancer, Foresee Pharmaceuticals announced. urologytimes.com

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