Orchid Chemicals and Pharmaceuticals Ltd has received the formal approval from the US FDA for its ANDA (abbreviated new drug application) for cefprozil for oral suspension USP, 125 mg / 5 ml and 250 mg /5 ml.
According to a company release, cefprozil is the generic version of Bristol-Myers Squibb's broad-spectrum cephalosporin antibiotic Cefzil. The current US market size for cefprozil oral suspension is USD 120 million.
Orchid Chemicals is launching the product in the US exclusively through its marketing alliance partner, Par Pharmaceuticals.
The company has already received the US FDA approval for cefprozil tablets USP, 250 mg and 500 mg and has commenced marketing it in the US in distribution alliance with Par. Together, the tablets and suspension forms have a current brand sale of USD 237 million.