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.
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.