quadrivalent (Types 6, 11, 16,
and 18) recombinant vaccine
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
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).