Lupin receives FDA approval for generic Monodox capsules and Cipro for oral suspension

Lupin has received final approval for its Doxycycline capsules USP, 50 mg, 75 mg, and 100 mg from the United States Food and Drugs Administration (FDA) to market a generic version of Aqua Pharmaceuticals Monodox capsules 50 mg, 75 mg, and 100 mg.

Lupin’s doxycycline capsules 50 mg, 75 mg and 100 mg are the AB-rated generic equivalents of Aqua Pharmaceuticals, LLC’s Monodox capsules 50 mg, 75 mg and 100 mg and are indicated in the treatment of infections caused by various micro-organisms and as an adjunctive therapy in severe acne.

The company also received final approval from the FDA for its ciprofloxacin for oral suspension, 5 g/100 mL (250 mg/5 mL) and 10 g/100 mL (500 mg/5 mL) to market a generic version of Bayer HealthCare Pharmaceuticals (Bayer) Cipro for oral suspension 5 g/100 mL and 10 g/100 mL.

Lupin’s ciprofloxacin oral suspension, 5 g/100 mL (250 mg/5 mL) and 10 g/100 mL (500 mg/5 mL) is the generic equivalent of Bayer’s Cipro oral suspension 5 g/100 mL (250 mg/5 mL) and 10 g/100 mL (500 mg/5 mL) and indicated for the treatment of infections caused by susceptible isolates of the designated micro-organisms in various conditions and patient populations.

Lupin is the first applicant to file an ANDA for Cipro oral suspension 250 mg/ml & 500 mg/ml and as such is entitled to 180 days of marketing exclusivity. Lupin Pharmaceuticals, the company’s US subsidiary would commence marketing the products shortly.

Monodox capsules had annual US sales of $180.6 million (IMS MAT Dec, 2013) whereas Cipro oral suspension had annual US sales of $8.6 million (IMS MAT Dec, 2013).

EP News Bureau – Mumbai