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Alembic Pharma bags USFDA final nod for orthostatic hypotension tablets

Our Bureau Ahmedabad | Updated on January 22, 2021

Alembic Pharmaceuticals R&D BioEquivalance Centre at Vadodara in Gujarat

Alembic Pharmaceuticals Limited has received the US drug regulator- US Food & Drug Administration (USFDA)'s approval 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 size of USD 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.

Alembic Pharmaceuticals shares ended at ₹940.65 on Friday, down about 1 per cent from its previous close on BSE.

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Published on January 22, 2021
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