FDA approves GSK’s HPV vaccine
PHILADELPHIA Merck & Co.’s highly successful human papillomavirus vaccine Gardasil has a new competitor.
The Food and Drug Administration approved GlaxoSmithKline’s Cervarix (human papillomavirus bivalent [types 16 and 18] vaccine, recombinant), for preventing infection by HPV – the virus that causes genital warts and can cause cervical cancer – in girls and women ages 10 to 25.
“The approval of Cervarix will bring an important new cervical cancer vaccine to girls and young women,” GSK president North American pharmaceuticals Deirdre Connelly said in a statement. “Immunization with a vaccine such as Cervarix – along with annual doctor visits and Pap tests – will help protect women from cervical cancer, the second leading cause of cancer death in women in their 20s and 30s.”
The FDA has already approved Merck’s Gardasil (human papillomavirus quadrivalent [types 6, 11, 16 and 18] vaccine, recombinant) for females and males ages 9 to 26.
Actress Olympia Dukakis, husband to appear in diabetes ads
NEW YORK Passengers in New York taxis and viewers watching CNN at the airport will see actress Olympia Dukakis and her husband, Louis Zorich, talking about diabetes.
The appearance of the two actors won’t be in a movie, but in a public service announcement that’s part of drug maker Novo Nordisk’s “Ask. Screen. Know.” campaign to encourage diabetes awareness among the elderly.
FDA approves generic epilepsy treatment
PITTSBURGH Generic drug maker Mylan has received the Food and Drug Administration’s approval for its version of a drug used to treat epilepsy.
Mylan announced Thursday the approval of its topiramate sprinkle capsules in the 15-mg and 25-mg strengths. The capsules are designed to be opened and sprinkled onto soft food and are a generic version of Johnson & Johnson’s Topamax Sprinkle Capsules.
The branded version of the drug had sales of $58 million for the 12-month period ended June 30, according to IMS Health data.