Ranbaxy Laboratories Limited (Ranbaxy) has received approval from the US Food and Drug Administration (USFDA) to market Panixine DisperDose (Cephalexin Tablets for Oral Suspension, 125 mg and 250 mg), stated a company release.
The Office of Generic Drugs, USFDA, has determined that Ranbaxy's Panixine DisperDose Tablets for Oral Suspension 125 mg and 250 mg (Cephalexin Tablets for Oral Suspension, 125 mg and 250 mg) can be expected to have the same therapeutic effect as an equivalent dose of Keflex for Oral Suspension 125 mg/5 mL and 250 mg/5 mL respectively of Ceph International Corp, the release said. The total market for Cephalexin was valued at $148 million with suspensions accounting for $32 million (IMS - MAT: June 2003).
Cephalexin represents the second most prescribed anti-infective agent in the U.S. 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. Since Panixine DisperDose is a tablet, not requiring refrigeration, it can be taken anywhere.
The Brand Products Division (B.P.D.) of Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy, will be responsible for commercializing and providing marketing support for this novel dosage form under the brand name Panixine DisperDose. The newly formulated dispersible tablet dosage form will add prescribing flexibility and clinical utility to this molecule. Ranbaxy' s B.P.D., has been created with the specific mission of launching brand name products that will materialize through the Ranbaxy pipeline in the years to come.
Panixine DisperDose will be distributed by RPI to all classes of trade including wholesalers, distributors and retail pharmacies on a nationwide basis from October 2003 in anticipation of the upcoming respiratory season. This new dispersible tablet dosage form will complement Ranbaxy's suspensions and capsule dosage forms for this molecule, which are available under the Ranbaxy label. This allows Ranbaxy to offer both suspension and capsule dosage forms, as well as Cephalexin in a dispersible tablet dosage form (Panixine DisperDose), thus allowing prescribers to more effectively meet the dosage administration needs of all patients.
Commenting on the approval, Dipak Chattaraj, president, RPI, said, "This addition to the already extensive line of anti-infectives available from Ranbaxy once again demonstrates the company's commitment to this therapeutic category thru this value added dosage form that will provide a worthwhile contribution to patient care and to the overall U.S. healthcare system. Ranbaxy's newly formulated dispersible tablet represents a new and improved way of taking a well-defined and dependable product. DisperMox (Amoxicillin Tablets for Oral Suspension) was introduced recently, and now with the same novel dosage form available for Cephalexin, Ranbaxy offers prescribing flexibility to physicians and ease of administration to patients and caregivers".
Based in Princeton, New Jersey, RPI is a wholly owned subsidiary of RLL, India having established operations in the U.S. in 1994 and launching its first prescription product in January 1998, following FDA approval in August 1997. For the year 2002, U.S. operations achieved sales of U.S. $ 296 Mn, a growth of 162 per cent over the corresponding year. During 2002, RPI filed 23 ANDAs (surpassing its target of 15-20 ANDA filings annually) and received 11 approvals. RPI markets a basket of generic products covering major therapeutic areas. In 2002, RPI was ranked as the 9th largest company in the U.S. generics market.