Ranbaxy Lab Gets USFDA Nod For Panixine Drug

New Delhi, September 16: | Updated: Sep 17 2003, 05:30am hrs
Ranbaxy Laboratories has received approval from the US Food and Drug Administration (USFDA) to market Panixine DisperDose, the brand name for Cephalexin tablets for oral suspension in 125 mg and 250 mg strengths.

The USFDA has determined Panixine DisperDose tablets for oral suspension in 125 mg and 250 mg strengths to have the same therapeutic effect as an equivalent dose of Keflex for oral suspension in 125 mg/5 mL and 250 mg/5 mL strengths respectively of Ceph International Corp.

The total market for Cephalexin was valued at $148 million (Rs 690 crore) with suspensions accounting for $32 million (Rs 145 crore) according to a release. Cephalexin represents the second most prescribed anti-infective agent in the US market for a variety of clinical indications such as the treatment of respiratory tract infections, otitis media, skin and skin structure infections, bone infections, and genitourinary tract infections, including acute prostatitis.

Cephalexin tablets for oral suspension (Panixine DisperDose) is a semi-synthetic cephalosporin antibiotic formulated by Ranbaxy in a new dosage form as a dispersible tablet for oral administration.

This new dosage form of Cephalexin will be especially beneficial to patients, who cannot swallow solid dosage forms and as an alternative to the oral suspension of Cephalexin according to the company. Since Panixine DisperDose is a tablet, not requiring refrigeration, it can be taken anywhere.

The brand products division of Ranbaxy Pharmaceuticals Inc, a wholly owned subsidiary of Ranbaxy in the USA, will be responsible for commercializing and providing marketing support for this novel dosage form under the brand name Panixine DisperDose.