FDA approves genital warts vaccine in males
ROCKVILLE, Md. The Food and Drug Administration has approved a genital warts vaccine for use in males.
The FDA announced the approval of Merck & Co.’s Gardasil (human papillomavirus quadrivalent [types 6, 11, 16 and 18] vaccine, recombinant) for the prevention of HPV infection in boys and men ages 9 to 26 years. HPV infects 2-in-1,000 men in the United States each year. It also is a leading cause of cervical cancer in women.
“This vaccine is the first preventive therapy against genital warts in boys and men ages 9 through 26 and, as a result, fewer men will need to undergo treatment for genital warts,” FDA Center for Biologics Evaluation and Research acting director Karen Midthun said in a statement.
The FDA approved a competitor drug, GlaxoSmithKline’s Cervarix (HPV bivalent [types 16 and 18] vaccine, recombinant), for use in girls and women last week.
Sandoz launches two products
PRINCETON, N.J. The generics arm of drug maker Novartis has launched two new products.
Sandoz announced the launch of topiramate sprinkle capsules, a generic version of Johnson & Johnson’s epilepsy drug Topamax Sprinkle, and calcium acetate capsules, an authorized generic of Fresenius Medical Care’s kidney failure drug PhosLo.
Topiramate capsules had sales of $56 million during the 12-month period ending in August, and PhosLo had sales of $42 million during the same period, according to IMS Health data.
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.