Human papillomavirus quadrivalent (Types 6, 11, 16, and 18) recombinant vaccine Gardasil® Merck & Co., Inc. | The US FDA granted an additional indication to this human papillomavirus (HPV) recombinant vaccine in December 2010 for the prevention of anal cancer caused by HPV types 16 and 18 and for the prevention of anal intraepithelial neoplasia (AIN) grades 1, 2 and 3 (anal dysplasias and precancerous lesions) caused by HPV types 6, 11, 16 and 18, in males and females 9 to 26 years of age. |
Daptomycin for injection Cubicin® Cubist Pharmaceuticals, Inc. | The US FDA approved this currently-marketed antibiotic for once-a-day dosing as a 2-minute intravenous (IV) injection in December 2010 for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) complicated skin infections and bacteremia. In addition to 2-minute IV injection, several other changes to the drug’s label were incorporated. These include changes and reformatting of the Warnings and Precautions in the label, updates to the Post Marketing Experience section of the label, and re-formatting of the label to be compliant with the FDA’s Physician Labeling Rule (PLR). |