The approval will allow the company to manufacture and market the generic equivalent of Warner Chilcott Company’s Durice for Oral Suspension 250mg/5mL and 500mg/5mL.
Cephalosporin antibiotic is indicated for patients with urinary tract infections caused by E.coli, P.mirabilis, and Klebsiella species, kin and skin structure infections caused by staphylococci and/or streptococci and Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes.
The approval was out of Unit VI Cephalosporin formulations manufacturing facility in Hyderabad, India, according to the company.