Pharma major, Lupin Ltd., announced today that its subsidiary, Lupin Pharmaceuticals Inc. (collectively, Lupin) 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 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."