Business EconomyPosted at: Sep 17 2018 3:24PM

Alembic Pharmaceuticals gets USFDA approval for Desvenlafaxine Extended Release Tablets, 25 mg

Mumbai, Sep 17 (UNI) Pharma Major, Alembic Pharmaceuticals Limited on Monday said that the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Des enlafaxine Extended-Release Tablets, 25 mg.
The approved ANDA is therapeuticall equivalent to the reference listed drug product (RLD), PRISTIQ ExtendedRelease Tabl ts, 25 mg of Wyeth Pharma Inc. Desvenlafaxine Extended-Release Tablets, 25 mg are
indica ed for the treatment of major depressive disorder (MOD), the company said in a filing with BSE.
Desvenlafaxine Extended-Release Tablets, 25 mg has an estimated market size of USD 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.
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Alembic Pharmaceuticals gets USFDA approval for Desvenlafaxine Extended Release Tablets, 25 mg

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