The approved product is therapeutically equivalent to the reference-listed drug product (RLD) Sinequan Capsules of Pfizer Inc.
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Doxepin Hydrochloride Capsules USP in the strengths of 10 mg, 25 mg, 50 mg, 75 mg and 100 mg, Alembic Pharmaceuticals said in a regulatory filing.
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Doxepin Hydrochloride Capsules are recommended for the treatment of psychoneurotic patients with depression and/or anxiety, depression and/or anxiety associated with alcoholism, depression and/or anxiety associated with organic disease and psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.
Quoting IQVIA data, Alembic Pharma said Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg have an estimated market size of USD 41 million for twelve months ending December 2020.
Alembic now has a total of 141 ANDA approvals (124 final approvals and 17 tentative approvals) from USFDA.