- Final approval for 12.5 mg extended-release tablets expands psychiatric care offerings
- Drug deemed equivalent to Paxil CR for multiple mental health indications
- Company’s USFDA tally rises to 235 ANDA approvals
NE BUSINESS BUREAU
MUMBAI, MAR 30
Alembic Pharmaceuticals Limited on Monday announced that it has received final approval from the US Food and Drug Administration (USFDA) for its supplemental Abbreviated New Drug Application (sANDA) for Paroxetine Extended-Release Tablets USP, 12.5 mg.
The approved formulation has been declared therapeutically equivalent to the reference listed drug (RLD), Paxil CR Tablets, 12.5 mg, marketed by Apotex Inc..
Paroxetine extended-release tablets are prescribed for the treatment of multiple mental health conditions, including Major Depressive Disorder (MDD), Panic Disorder (PD), Social Anxiety Disorder (SAD), and Premenstrual Dysphoric Disorder (PMDD).
“The approval reinforces our commitment to expanding our portfolio of high-quality, affordable medicines in the US market,” the company stated.
With this latest nod, Alembic’s cumulative tally now stands at 235 ANDA approvals from the USFDA, comprising 216 final approvals and 19 tentative approvals, further consolidating its presence in the highly regulated US generics space.
