NEW DELHI: (Apr 9) Glenmark Pharmaceuticals on Thursday said it has received final approval from the US health regulator for its generic version of progesterone vaginal inserts used in fertility treatments.
The approval by the US Food and Drug Administration (USFDA) is for progesterone vaginal inserts of strength 100 mg, Glenmark Pharmaceuticals Ltd said in a regulatory filing.
It has been determined by the USFDA to be bioequivalent and therapeutically equivalent to the reference listed drug, Endometrin vaginal inserts, 100 mg of Ferring Pharmaceuticals Inc, it added.
Source: PTI News
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