• Lupin Ltd., of Mumbai, India, said its subsidiary, Lupin Pharmaceuticals Inc., received approval for Suprax (cefixime) for oral suspension, 500 mg/5mL from the FDA. 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/5-ml and 200-mg/5-ml suspensions; 400-mg tablets as well as chewable tablets 100 mg and 200 mg. The new drug application provides for a new strength for the treatment of otitis media, acute exacerbation of chronic bronchitis, uncomplicated urinary tract infections, uncomplicated gonorrhea (cervical/urethral) and pharyngitis/tonsillitis.

• Sanofi Pasteur, of Lyon, France, the vaccines division of Sanofi SA, said the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended market approval for Sanofi Pasteur's 6-in-1 pediatric vaccine Hexyon/Hexacima, the only fully liquid, ready-to-use, 6-in-1 vaccine to protect infants against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.