Alembic Pharmaceuticals receives USFDA approval for Midodrine Hydrochloride Tablets
Alembic Pharmaceuticals announced that 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 ...
Source: business-standard.com