Alembic Pharmaceuticals Ltd announces USFDA Final Approval for Paroxetine Extended Release Tablets USP, 25 mg and 37.5 mg.

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Paxil CR Extended-Release Tablets, 25 mg and 37.5 mg, of Apotex Inc. Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg, are indicated for the treatment of Major depressive disorder (MDD), Panic disorder (PD), Social anxiety disorder (SAD), and Premenstrual dysphoric disorder (PMDD). Refer label for a detailed indication.

Alembic has a cumulative total of 226 ANDA approvals (205 final approvals and 21 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 919.55 as compared to the previous close of Rs. 940.25. The total number of shares traded during the day was 2959 in over 392 trades.

The stock hit an intraday high of Rs. 940.50 and intraday low of 917.50. The net turnover during the day was Rs. 2756443.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA FinalApproval Paroxetine ExtendedReleaseTablets