Last Updated on January 23, 2021 by The Health Master
Alembic Pharmaceuticals Limited 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).
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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 US FDA.
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