Lupin said on Thursday that it has received US health regulator USFDA’S approval to market a generic version of Bayer’s Cipro, used to treat infections, in the American market.
The company has received the final approval from the US Food and Drug Administration (USFDA) to market its Ciprofloxacin for oral suspension in the American market in various strengths, Lupin said in a statement.
Cipro oral suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in various conditions and patient populations.
“Lupin is the first applicant to file an abbreviated new drug application (ANDA) for Cipro oral suspension 250 mg/ml and 500 mg/ml and as such is entitled to 180-days of marketing exclusivity,” the Mumbai-based company said.
Lupin Pharmaceuticals Inc (LPI), the company’s US subsidiary, would commence marketing the products shortly, it added.
The company has also received USFDA’s final approval to market generic version of Aqua Pharmaceuticals’ Monodox Capsules in the American market.
Lupin’s Doxycycline Capsules in strengths of 50mg, 75mg and 100mg are the generic equivalents of Aqua Pharmaceuticals, LLC’s Monodox Capsules and are indicated in the treatment of infections caused by various microorganisms and as an adjunctive therapy in severe acne, the company said.
According to IMS MAT Dec, 2013 sales data, Monodox Capsules had annual US sales of $ 180.6 million while Cipro Oral Suspension had annual sales of $ 8.6 million.
Lupin shares today closed at Rs 981.70 a piece on the National Stock Exchange, down 0.72 per cent from its previous close.