U.S. FDA Approval and CGT Exclusivity for AB-Rated Bioequivalent Tablets of PREMARIN®

Novast Laboratories Limited Announces U.S. FDA Approval and CGT Exclusivity for AB-Rated Bioequivalent Tablets of PREMARIN®
Nantong, China – Novast Laboratories Limited, a leading global pharmaceutical research, development, and manufacturing company, is pleased to announce that it has received final approval from the U.S. Food and Drug Administration (FDA) on October 15, 2025, for its AB-rated bioequivalent generic tablets of PREMARIN® (conjugated estrogens), a product manufactured and distributed by Pfizer Inc.
The approved product includes the following tablet strengths:
Conjugated Estrogens Tablets, USP 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg
In addition, the FDA has granted Competitive Generic Therapy (CGT) designation for Novast’s product, providing 180 days (six months) of marketing exclusivity upon commercial launch in the United States. This milestone highlights Novast’s continued innovation in complex hormone formulations and its mission to expand patient access to high-quality, affordable medicines.