Theravance Inc and partner Astella Pharma won the FDA approval for their superbug-fighting drug telavancin. The drug will hit the market in the fourth quarter as a treatment for adults with complicated skin and skin structure infections caused by methicillin-resistant Staphylococcus aureus, commonly known as the superbug MRSA and other Gram-positive bacteria. The drug is the first approved specifically to target MRSA, which currently is treated largely with the antibiotic vancomycin.

Hospira has obtained approval for its anti-infective Azithromycin injection from the FDA. Azithromycin is a generic variant of Pfizer’s Zithromax and is ADD-Vantage system compatible. ADD-Vantage is an advanced drug delivery system that does not need a needle and syringe to mix the drug with the solution. This lowers the risk of accidental needle pricks, improves workflow and prevents waste due to stability and shelf-life elements.

Aurobindo Pharma Ltd., headquartered in India, has received FDA approval to market the 300mg strength of its Cefdinir capsules in the US. Cefdinir is a generic version of Abbott Laboratories’ Omnicef, which is used to treat or prevent bacterial infections. According to IMS Health, Omnicef sales totaled about $787 million in 2006. Aurobindo Pharma already has FDA approval to market the 125mg and 250mg strengths of Cefdinir capsules.