Alembic Pharma gets USFDA final approval for Doxepin Hydrochloride Capsules

Alembic Pharmaceuticals announced it has received final approval from the US Food & Drug Administration (USFDA) 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.

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.

Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg have an estimated market size of $41 million for twelve months ending December 2020 according to IQVIA.

Alembic has a cumulative total of 141 ANDA approvals (124 final approvals and 17 tentative approvals) from USFDA.