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

Date: Feb-26-2013
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."

Courtesy: Medical News Today
Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.