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Alembic Pharmaceuticals (Alembic) on 22 January 2020 announced that it 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 drug is indicated for the treatment of symptomatic orthostatic hypotension (OH).
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), ProAmatine tablets of Takeda Pharmaceuticals USA, Inc. (Takeda).
Midodrine hydrochloride tablets have an estimated market size of $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 is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.
The drug maker reported 25% jump in consolidated net profit to Rs 293 crore on a 9% rise in net sales to Rs 1314 crore in Q3 FY21 over Q3 FY20.
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