Lupin bags US FDA approval

Generic lumigan ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients

Lupin has received final approval for its bimatoprost ophthalmic solution, 0.03 per cent from the United States Food and Drugs Administration (US FDA) to market a generic version of Allergan’s Lumigan Ophthalmic Solution, 0.03 per cent. Lupin Pharmaceuticals Inc (LPI), the company’s US subsidiary would commence marketing the product shortly.

Lupin’s bimatoprost ophthalmic solution, 0.03 per cent is the AT rated generic equivalent of Lumigan ophthalmic solution, 0.03 per cent and is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

Lupin’s bimatoprost ophthalmic solution, 0.03 per cent filing was made from its Indore facility which was audited in January, 2015. Two Lupin facilities, the Lupin Bioresearch Center, Pune (LBC) and its manufacturing facility at Pithampur, near Indore were audited by the US FDA in November, 2014 and January, 2015 respectively. Both the audits were completed successfully with LBC not receiving any observations and the Indore facility receiving six observations (483’s). Since then, the Indore facility has received one ANDA approval and two site-transfer approvals.