Alembic Pharma secures USFDA nod for Midodrine Hydrochloride Tablets
Midodrine Hydrochloride Tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH).
Vadodara: Alembic Pharmaceuticals Limited has recently announced that the company 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.
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.
Read also: Alembic Pharma Net profit rises 25 percent to Rs 293 crore in Q3
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company headquartered in Gujarat.
