Drug firm Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator for Midodrine Hydrochloride tablets, which are used to treat orthostatic hypotension.
The approved product is therapeutically equivalent to the reference listed drug product ProAmatine tablets of Takeda Pharmaceuticals USA, Inc.
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Midodrine Hydrochloride tablets in the strength of 2.5 mg, 5 mg, and 10 mg, Alembic Pharmaceuticals said in a regulatory filing.
Midodrine Hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH).
The drug is used for certain patients who have symptoms of low blood pressure when standing. This condition is also known as orthostatic hypotension.
Quoting IQVIA data, Alembic Pharma said 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.
Alembic now has a total of 138 ANDA approvals (120 final approvals and 18 tentative approvals) from USFDA.