Mumbai: Ranbaxy Laboratories has received final approval from US Food and Drug Administration (USFDA) to make and sell Clarithromycin, a drug used for treating infections.
Ranbaxy is the first company to have been granted a generic approval for the oral suspension form along with Clarithromycin tablets, the company said in a filing to the Bombay Stock Exchange.
The USFDA approval was granted for strengths of 125 mg/5 mL and 250 mg/5 mL, it said.
This approval will add depth to the company’s product line of anti-infectives that also includes Clarithromycin tablets, Jim Meehan, vice-president of sales and distribution in Ranbaxy Pharmaceuticals Inc (RPI), said.
Florida-based RPI is a wholly-owned subsidiary of Ranbaxy and sells generic and branded prescription products in the US.
Total annual market sales for Clarithromycin were $99.7 million with suspension sales totalling $25.3 million as per IMS MAT June 2007 figure.
“RPI will be in a position to offer both dosage forms for this molecule that will distinguish Ranbaxy in the market place,” Meehan added.
As per USFDA, the Ranbaxy formulation is bio-equivalent and has the same therapeutic effect as that of the reference listed drug Biaxin Granules in the strength of 125 mg/5 mL and 250 mg/5 mL of Abbott Laboratories.
Ranbaxy shares were trading at Rs442, up 0.78% on BSE in afternoon trade.