The final approval granted by the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) prucalopride tablets of strengths 1 mg and 2 mg, Alembic said in a statement.
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The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Motegrity tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA Inc, it added.
Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
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Citing IQVIA data, the company said prucalopride tablets, 1 mg and 2 mg, had an estimated market size of USD 100 million for 12 months ended March 2026.
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