Lupin gets FDA nod for Generic Monodox Capsules

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

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Lupin gets FDA nod for Generic Monodox Capsules

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

Lupin's Doxycycline Capsules 50mg, 75mg and 100mg are the AB rated generic equivalents of Aqua Pharmaceuticals, LLC's Monodox Capsules 50mg, 75mg and 100mg and are indicated in the treatment of infections caused by various microorganisms 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, Inc.'s (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 microorganisms in various conditions and patient
populations.

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