Alembic Pharmaceuticals (Alembic), a vertically integrated research and development pharmaceutical company on January 22 announced it has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Midodrine Hydrochloride Tablets USP, 2.5 mg, 5 mg, and 10 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), ProAmatine Tablets, 2.5 mg, 5 mg, and 10 mg, of Takeda Pharmaceuticals USA, Inc. (Takeda).

Midodrine Hydrochloride Tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH).

Midodrine Hydrochloride Tablets USP 2.5 mg, 5 mg, and 10 mg have an estimated market size of USD 60 million for twelve months ending September 2020 according to IQVIA.

Alembic has a cumulative total of 138 ANDA approvals (120 final approvals and 18 tentative approvals) from USFDA.

Shares of the company gained Rs 0.9, or 0.09%, to trade at  Rs 951.65.  The total volume of shares traded  was  33,709 at the BSE (12.06 p.m., Friday).