FDA grants Alembic’s generic Synjardy tentative approval

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FDA grants Alembic’s generic Synjardy tentative approval

By Sandra Levy - 07/21/2020

The Food and Drug Administration has given a tentative nod to Alembic for its generic Synjardy (empagliflozin and metformin hydrochloride tablets)

Alembic's generic of Boehringer Ingelheim's branded drug has been tenatively approved in dosage strengths of 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg.

Empagliflozin and metformin hydrochloride tablets have a market value of roughly $172 million for the 12 months ended March 2020, according to IQVIA.

Alembic currently is in litigation with Boehringer lngelheim in the District Court of Delaware and launch of the product will depend on litigation outcome.

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