Aurobindo Pharma has received US FDA's final approval for Clindamycin Hydrochloride capsules USP 150mg (base) and 300mg. Similarly, Swissmedic, Government of Switzerland has approved the license of Cefepime APL for Injection 1g and 2g.
Clindamycin Hydrochloride capsules USP 150mg (base) and 300mg (base) are generic equivalent to Cleocin Hydrochloride capsules 150mg and 300 mg of Pharmacia and Upjohn Company. Clindamycin Hydrochloride is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria and falls under the anti-infective therapeutic segment. The product has a market size of approximately US$ 55 million for the twelve months ending March 2009, according to Newport. The product will be launched shortly. Aurobindo now has a total of 101 ANDA approvals (73 final approvals and 28 tentative approvals) from US FDA.
Cefepine APL for Injection 1g and 2g falls under the anti-beta-lactam segment and is indicated for moderate to severe pneumonia, UTI, skin and skin structure infections, intra-abdominal infections. This is Aurobindo's second product approval from Swissmedic.