Alembic Pharma receives USFDA approval for doxepin

Alembic Pharma receives USFDA approval for doxepin

Alembic Pharmaceuticals has received the USFDA approval for its abbreviated new drug application (ANDA) 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), Sinequan Capsules 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, of Pfizer Inc. (Pfizer).

Doxepin hydrochloride capsules are recommended for the treatment of:
i) Psychoneurotic patients with depression and/or anxiety,
ii) Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol),
iii) Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly),
iv) Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.