Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paroxetine Extended-Release Tablets USP. The tablets, available in 25 mg and 37.5 mg strengths, are therapeutically equivalent to Apotex Inc.’s Paxil CR Extended-Release Tablets and treat conditions such as Major Depressive Disorder and Panic Disorder.
USFDA Approval Received
Alembic Pharmaceuticals Limited announced on September 25th, 2025, that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) regarding Paroxetine Extended-Release Tablets.
Paroxetine Tablets Details
The approved ANDA is for Paroxetine Extended-Release Tablets USP, available in strengths of 25 mg and 37.5 mg. These tablets are therapeutically equivalent to Apotex Inc.’s Paxil CR Extended-Release Tablets of the same strengths.
Therapeutic Use
Paroxetine Extended-Release Tablets USP are indicated for the treatment of several conditions, including:
- Major depressive disorder (MDD)
- Panic disorder (PD)
- Social anxiety disorder (SAD)
- Premenstrual dysphoric disorder (PMDD)
Alembic’s ANDA Approvals
With this approval, Alembic Pharmaceuticals now has a cumulative total of 226 ANDA approvals from the USFDA, consisting of 205 final approvals and 21 tentative approvals.
Source: BSE
