Lupin Receives FDA Approval For New Drug Application For SUPRAX® Oral Suspension, 500 Mg/5mL

Main Category: Regulatory Affairs / Drug Approvals
Article Date: 26 Feb 2013 - 1:00 PST


Approval to add to growing SUPRAX(R) Franchise

Pharma major, Lupin Ltd., announced last week that its subsidiary, Lupin Pharmaceuticals Inc. (collectively, Lupin) has received approval for SUPRAX(R) (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(R) dosage forms available to treat approved indications in appropriate patients. SUPRAX(R) is currently available as 100 mg/5ml and 200 mg/5ml suspensions; 400 mg tablets as well as chewable tablets 100 & 200 mg.

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

Commenting on the approval, Ms. Vinita Gupta, Group President, Lupin Limited & CEO, Lupin Pharmaceutical Inc. said "We are happy to receive this approval. The new dosage form will add to our growing SUPRAX franchise and gives health care providers and patients a new formulation to treat the indicated infections. The approval of SUPRAX for Oral Suspension is one more example of our ongoing commitment to serving our customers and addressing their needs."

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