Updated on 25 February 2013
Good news for otitis, bronchitis, gonorrhea and pharyngitis patients - Lupin Pharmaceuticals Suprax (Cefixime) oral suspension (500 mg/5mL) gets approval from US FDA
Mumbai: Lupin subsidiary, Lupin Pharmaceuticals, received approval for Suprax (Cefixime) for oral suspension, 500 mg/5mL from the US FDA. Lupin expects to commence shipping of the product soon.
The approval will expand Lupin's range of Suprax dosage forms that are 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 of 100 and 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, and CEO, Lupin Pharmaceuticals, said that, "We are happy to receive this approval. The new dosage form will add to our growing Suprax franchise and gives healthcare 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."