Alembic gets approval for 2 generics
Alembic Pharmaceuticals has received the Food and Drug Administration’s nod for pramipexole dihydrochloride ER tablets in 0.375-mg, 0.75-mg, 1.5-mg, 2.25-mg, 3 mg, 3.75-mg and 4.5-mg dosage strengths.
The product, which is the generic of Boehringer lngelheim’s Mirapex ER tablets, is indicated for the treatment of Parkinson’s disease.
Pramipexole dihydrochloride ER tablets had a market value of roughly $38.6 million for the 12 months ending December 2017, according to IQVIA.
Alembic also received the FDA’s approval for olopatadine hydrochloride ophthalmic solution 0.1 %.
The product, which is the generic of Novartis’ Patanol ophthalmic solution 0.1 %, is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.
Olopatadine hydrochloride ophthalmic solution had a market value of about $61 million for the 12 months ending December 2017, according to IQVIA.
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