Ranbaxy Laboratiories Ltd, India's largest drug firm by revenue, on Friday said it has received US Food and Drug Administration's (USFDA) final approval to manufacture and market anti-bacterial drug oral Clarithromycin in multiple strengths.
Clarithromycin is used to treat certain infections caused by bacteria, such as pneumonia, bronchitis, and infections of ears, sinuses, skin, and throat.
Ranbaxy is the first company to have been granted approval for both generic oral suspension form and Clarithromycin tablets. The market for the drug is estimated to be around $99.7 million to which suspension sales contribute $25.3 million, the company said in a statement.
The company has received an approval to manufacture and market Clarithromycin for oral suspension, USP in multiple dosages of 125 mg/5 ml and 250 mg/5 ml.
"We are pleased to receive this FDA approval for Clarithromycin for Oral Suspension, it will add depth to our product line of anti-infectives which also includes Clarithromycin tablets," Ranbaxy Pharmaceuticals Inc Vice President of Sales and Distribution Jim Meehan said.
Clarithromycin for Oral Suspension, USP is a generic version of Abbott Laboratories Biaxin Granules.
USFDA determined the Ranbaxy's formulation to be bioequivalent and to have the same therapeutic effect as that of Abbot's Biaxin Granules 125 mg/5 ml and 250 mg/5 ml.
Ranbaxy Pharmaceuticals Inc is a wholly-owned subsidiary of Ranbaxy Laboratories Limited (RLL). The company is engaged in sales and distribution of generic and branded prescription.