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Glenmark Gets FDA Approval for Bioequivalent Progesterone Vaginal Insert

Sales of the reference listed drug, Endometrin, tallied approximately $59.2 million in a 12-month period ending February 2026.

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By: Patrick Lavery

Content Marketing Editor

Glenmark Pharmaceuticals has final approval from the U.S. FDA for its progesterone vaginal inserts in 100-mg dose. The FDA determined the inserts are bioequivalent, as well as therapeutically equivalent, to the reference listed drug. That drug, known by the brand name Endometrin, is made by Ferring Pharmaceuticals. It too is available in 100-mg dose. FDA Defines Progesterone Purpose The FDA prescribing information for the Ferring reference drug says it supports “embryo implantation a...

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