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Alembic Pharma bags USFDA final nod for orthostatic hypotension tablets


Alembic Pharma bags USFDA final nod for orthostatic hypotension tablets
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. ....

Takeda Pharmaceuticals United States Inc , Alembic Pharmaceuticals , Us Food Drug Administration , Alembic Pharmaceuticals Limited , Drug Administration , Abbreviated New Drug Application , Midodrine Hydrochloride Tablets , Proamatine Tablets , Takeda Pharmaceuticals United States , டாகேடா மருந்துகள் ஒன்றுபட்டது மாநிலங்களில் இன்க் , அலெம்பிக் மருந்துகள் , அலெம்பிக் மருந்துகள் வரையறுக்கப்பட்டவை , டாகேடா மருந்துகள் ஒன்றுபட்டது மாநிலங்களில் ,

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 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. ....

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