Lupin receives USFDA nod for bimatoprost ophthalmic solution

The US Food and Drugs Administration (USFDA) has given marketing approval for Lupin’s bimatoprost ophthalmic solution, 0.03%, - a generic version of Allergan Inc’s Lumigan solution. Lupin Pharmaceuticals Inc (LPI), the company’s US subsidiary, is expected to commence marketing the product shortly.
 
Lupin's bimatoprost ophthalmic solution, the AT rated generic equivalent of Lumigan ophthalmic solution, is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
 
Lupin's bimatoprost ophthalmic solution 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 (Form 483). Since then, the Indore facility has received 1 ANDA approval and 2 site-transfer approvals.