Lupin’s arm receives USFDA approval for SUPRAX Oral Suspension, 500 mg/5mL

Pharma major, Lupin’s subsidiary - Lupin Pharmaceuticals Inc has received approval for SUPRAX (Cefixime) for Oral Suspension, 500 mg/5mL from the United States Food and Drugs Administration (FDA). Lupin expects to commence shipping the product in the near future.

The approval will expand Lupin’s range of SUPRAX dosage forms available to treat approved indications in appropriate patients. SUPRAX is currently available as 100mg/5mg and 200mg/5mL suspensions; 400mg tablets as well as chewable tables 100 & 200mg.

This new drug application provides for a new strength, 500mg/5mL of SUPRAX (Cefixime) for Oral Suspension for the treatment of otitis, acute exacerbation of chronic bronchitis, uncomplicated urinary tract infections, uncomplicated gonorrhea (cervical/urethral) and pharyngitis/tonsillitis.

Lupin is the 5th largest and fastest growing generics player in the US (5.1% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales. The company is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa (IMS).