Aurobindo Pharma Ltd. said it had received final approval from the US FDA to manufacture and market Cefadroxil for Oral Suspension USP 250mg/5mL and 500mg/5mL covered under ANDA 065349.
Cefadroxil for Oral Suspension USP 250mg/5mL and 500mg/5mL is the generic equivalents of Warner Chilcott Co. Inc.'s Duricef for Oral Suspension USP 250mg/5mL and 500mg/5mL.
Cefadroxil for Oral Suspension USP 250mg/5mL and 500mg/5mL 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 company said the product had been approved out of Unit VI Cephalosporin formulations manufacturing facility in Hyderabad, India.
At the BSE, Aurobindo Pharma shares are currently trading at Rs.189, down 1.25 percent from the previous close.
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