Alembic Pharma Gets USFDA Nod for Generic Paxil CR Tablets
New Delhi: Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for 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, marketed by Apotex Inc.
The newly approved tablets are indicated for the treatment of Major Depressive Disorder (MDD), Panic Disorder (PD), Social Anxiety Disorder (SAD), and Premenstrual Dysphoric Disorder (PMDD). Alembic noted that the tablets will be marketed as per the approved USFDA label for detailed indications.
Commenting on the approval, Alembic Pharmaceuticals said, “We are pleased to announce USFDA final approval for Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg. This milestone reinforces our commitment to providing high-quality generic medications to patients globally.”
With this approval, Alembic has now achieved a cumulative total of 226 ANDA approvals from the USFDA, including 205 final approvals and 21 tentative approvals, highlighting the company’s growing footprint in the US generics market.
Alembic Pharmaceuticals Limited, headquartered in India, is a vertically integrated research and development company with a presence in branded generics and generic pharmaceuticals worldwide. The company’s manufacturing and research facilities are approved by multiple global regulatory authorities, including the USFDA. Its products are widely recognized by healthcare professionals and patients, with a marketing field force of over 5,500 employees across India.
