Hyderabad-based, Aurobindo Pharma has received final approval from the US Food & Drug Administration (FDA) to manufacture and market Cefadroxil for Oral Suspension USP 250mg/ 5mL and 500mg/ 5mL (ANDA 065349).
Cefadroxil for Oral Suspension USP, 250mg/ 5mL and 500mg/ 5mL is the generic equivalents of Warner Chilcott Company, Inc.’s Duricef for Oral Suspension 250mg/ 5mL and 500mg/ 5mL.
Cefadroxil for Oral Suspension is a cephalosporin antibiotic indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms such as urinary tract infections caused by E.coli, P.mirabilis, and Klebsiella species; skin and skin structure infections caused by staphylococci and/or streptococci; pharyngitis and/or tonsillitis caused by Streptococcus pyogenes.
The product has been approved out of Unit VI Cephalosporin formulations manufacturing facility in Hyderabad, India.
Aurobindo now has a total of 187 ANDA approvals (160 final approvals including four from Aurolife Pharma LLC and 27 tentative approvals) from US FDA.