Alembic Pharma gets US regulator nod for Doxepin Hydrochloride capsules

On Friday, Alembic Pharmaceuticals informed the exchanges that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Doxepin Hydrochloride Capsules, in the strengths of 10 mg, 25 mg, 50 mg, 75 mg and 100 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product, Sinequan Capsules of Pfizer Inc. This drug has an estimated market size of US$ 41 million for twelve months ending December 2020 according to IMS Health (IQVIA).

The abovementioned drug is recommended to treat depression and/or anxiety associated to alcoholism, organic disease, and for the treatment of psychoneurotic patients. In addition, it is recommended for psychotic depressive disorders with associated anxiety and manic-depressive disorders.

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

At 2 pm on Friday, the shares of Alembic Pharmaceuticals were trading at Rs 996.50, down by 0.72 per cent or Rs 7.20 per share, against a 0.28 per cent decline in the benchmark index. The 52-week high of the company is recorded at Rs 1,150 and the 52-week low is recorded at Rs 641.55 on BSE.