FDA Gives Approval to Lupin to Market Generic Cipro in US

The US Food and Drug Administration has given approval for Mumbai-based pharmaceutical company Lupin to market the generic versions of Bayer’s Cipro and Aqua Pharmaceuticals’ Monodox capsules in the American market. Confirming the approval, the company said that it has received permission to market Cipro oral suspension in 250 mg/ml and 500 mg/ml strengths while its Doxycycline Capsules, which are equivalent to Monodox capsules, will be marketed in strengths of 50mg, 75mg and 100mg.

Cipro is used in treating infections caused by susceptible isolates of the designated microorganisms in various conditions and patient populations while Monodox is used as an adjunctive therapy for severe acne

“Lupin is the first applicant to file an abbreviated new drug application (ANDA) for Cipro oral suspension 250 mg/ml & 500 mg/ml and as such is entitled to 180 days of marketing exclusivity. Lupin Pharmaceuticals Inc. (LPI), the company’s US subsidiary would commence marketing the products shortly”, the company said in a statement.



Source-Medindia