FDA APPROVES ORCHID'S CEPHALEXIN ANDA

Orchid Chemicals & Pharmaceuticals, based in Chennai, India, has received FDA approval for its abbreviated new drug application (ANDA) for cephalexin capsules USP in 250-, and 500-mg dosage strengths.

Cephalexin is a version of Advancis Pharmaceutical's cephalosporin Keflex (cephalexin). Keflex is used to treat infections of the ear, chest, skin, bones, bladder or gonorrhea. This is the first U.S. ANDA approval in the oral formulations segment for Orchid, the company said. Orchid will launch the product soon in the U.S. through its distribution partner, Par Pharmaceutical.