Cosette Pharmaceuticals Announces the Approval and Launch of First Generic Version of RECTIV® (nitroglycerin) ointment, 0.4%, with 180 days Competitive Generic Therapy (CGT) exclusivity
Cosette Pharmaceuticals, Inc. ("Cosette") announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Applications (ANDA) for the first generic version of RECTIV® (nitroglycerin) ointment, 0.4%, with 180 days Competitive Generic Therapy (CGT) exclusivity.
- Cosette Pharmaceuticals, Inc. ("Cosette") announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Applications (ANDA) for the first generic version of RECTIV® (nitroglycerin) ointment, 0.4%, with 180 days Competitive Generic Therapy (CGT) exclusivity.
- Cosette will imminently commence commercial shipments, triggering the 180 days exclusivity.
- This is Cosette’s 24th new product launch and our 3rd CGT approval in the last two years.
- Cosette currently has several products in active development, and several complex product ANDAs pending FDA approval.