Alembic Pharma gets final nod from USFDA for Midodrine Hydrochloride Tablets

Alembic Pharmaceuticals 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 US.

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 US$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.