Orchid Chemicals gets US approval for antibiotic tablet

Orchid Chemicals and Pharmaceuticals on Tuesday announced that the US Food and Drug Administration (FDA) approved the sale of Cefprozil tablets (part of cephalosporin family) made by the company in the US.

Cefprozil's patent in the US ends on Friday and Orchid and three other companies have so far been given permission to launch the generic version on the same day.

Orchid's launch will be through Par Pharmaceuticals, with whom Orchid has a marketing tie up for six other cephalosporin orals.

An Orchid press release said that the current market size for Cefprozil tablets is $ 117 million. Orchid has also sought permission to sell Cefprozil suspension, for which the market size is around $ 123 million.

As of now, Orchid has received the US FDA's approval for 250 mg and 500 mg Cefprozil tablets.

This is the company's eight cephalosporin formulation (ANDA) that the US FDA has approved for sale there. The eight ANDAs cover four different kinds of cephalosporins.