Ranbaxy gets USFDA approval for Clarithromycin

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New Delhi, Oct 4 (UNI) Ranbaxy Laboratories Ltd today said it has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Clarithromycin for Oral Suspension, USP, whose market sales are estimated at 25.3 million dollars.

''The suspension will be available in 125 mg/5 mL and 250 mg/5 mL strengths. We are the first company to have been granted a generic approval for the Oral Suspension form along with Clarithromycin Tablets, whose total annual market sales was 99.7 million dollars,'' a statement said.

Clarithromycin (Oral Suspension) is an anti-infective agent.

''This approval further expands our product portfolio of affordable generic alternatives and will he shipped immediately to all classes of trade,'' said Ranbaxy Pharmaceuticals Inc (RPI) Vice President (Sales and Distribution) Jim Meehan. RPI is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.

Clarithromycin is indicated for the treatment of Pharyngitis, Tonsillitis, Community-Acquired Pneumonia, uncomplicated skin and skin structure infections and disseminated mycobacterial infections.


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