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Alembic Pharma receives final USFDA approval for gPristiq

Alembic Pharmaceuticals has received final USFDA approval for Desvenlafaxine ER  Tablets, 25mg. Desvenlafaxine ER is indicated in the treatment of major depressive disorder (MOD). The approved ANDA is therapeutically equivalent to Wyeth Pharma Inc’s Pristiq ER, table 25mg.

According to IQVIA, Desvenlafaxine ER 25mg tablet had an estimated sales of $13.3mn in 2017. This is a small drug and we have low sales expectations from this drug. Alembic is already present in 50mg strength of this drug.

Alembic Pharma now has total 77 ANDA approvals (64 final approvals and 13 tentative approvals) from USFDA.

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