Alembic Pharma gets USFDA nod for low blood pressure treatment drugPTI | New Delhi | Updated: 22-01-2021 11:41 IST | Created: 22-01-2021 11:32 IST
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.
Alembic now has a total of 138 ANDA approvals (120 final approvals and 18 tentative approvals) from USFDA.
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