Alembic Pharmaceuticals gets FDA final approval for Doxepin Hydrochloride Capsules

Alembic Pharmaceuticals announces USFDA Final Approval for Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg and 100 mg.

Alembic Pharmaceuticals has secured final approval from the US Food & Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) – Pfizer’s Sinequan Capsules 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg.

Doxepin Hydrochloride Capsules are used for the treatment of psychoneurotic patients with depression and/or anxiety, depression and/or anxiety resulting from alcoholism, depression and/or anxiety related to organic disease, psychotic depressive disorders with associated anxiety.

Alembic Pharmaceuticals has a total of 141 ANDA approvals, which include 124 final approvals and 17 tentative approvals from the FDA.