Lupin approved for generic Monodox, Cipro

MUMBAI and BALTIMORE — Lupin on Thursday announced that it received final approval from the Food and Drug Administration for its doxycycline capsules USP, 50 mg, 75 mg and 100 mg, which is the generic version of Aqua Pharmaceuticals' Monodox capsules. The drug is used to treat infections caused by various microorganisms and as an adjunctive therapy in severe acne, according to the company.



The company also received FDA approval for its ciprofloxacin for oral suspension 5 g/100 mL (250 mg/5 mL) and 10 g/100 mL (500-mg/5-mL), a generic form of Cipro for oral suspension from Bayer HealthCare Pharmaceuticals. The drug is used for the treatment of infections caused by susceptible isolates of the designated microorganisms in various conditions and patient populations, the company said.



Monodox capsules had annual sales in the United States of 180.6 million for the year ending December 2013, according to IMS MAT data; Cipro oral suspension had sales of $8.6 millon.