Alembic Pharma gets USFDA’s nod for Desvenlafaxine Extended-Release Tablets

17 Sep 2018 Evaluate

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Desvenlafaxine Extended-Release Tablets, 25 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), PRISTIQ Extended-Release Tablets, 25 mg of Wyeth Pharma. Desvenlafaxine Extended-Release Tablets, 25 mg are indicated for the treatment of major depressive disorder (MDD).

Desvenlafaxine Extended-Release Tablets, 25 mg has an estimated market size of $ 13.3 million for twelve months ending December 2017 according to IQVIA

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

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.

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