FDA initiates review for decision on Watson’s prostate cancer drug
CORONA, Calif. The Food and Drug Administration could come to a decision on a prostate cancer drug made by Watson Pharmaceuticals by third quarter 2009.
Watson said Thursday that the FDA had accepted its approval application for a formulation of Trelstar (triptorelin pamoate) that suppresses the production of testosterone in men with advanced prostate cancer over six months. The new formulation requires an injection once every six months, while formulations on the market require injections every month or every three months.
“This filing reflects Watson’s commitment to urology and to making a difference in the lives of men living with prostate cancer,” Watson president and chief executive officer Paul Bisaro said in a statement.
FDA approves Mylan’s generic drug for treating epilepsy
ROCKVILLE, Md. The Food and Drug Administration has approved Mylan’s levetiracetam tablets, FDA records show.
The tablets, a generic version of UCB’s epilepsy drug Keppra, will be available in 250 mg, 500 mg and 750 mg dosages.
The agency’s records indicate an approval date of Nov. 4 and that Mylan’s is the first generic version of Keppra.
Study shows Gardasil is effective in prevention of HPV in males
ATLANTA A vaccine used to prevent genital warts in girls and women works in boys and men, too.
A study of Gardasil funded by its manufacturer, Merck, has shown that the vaccine is effective in preventing infection human papillomavirus in boys and men as well as in girls and women. The study took place in 20 countries among 4,000 boys and men aged 16 to 26, including more than 1,000 in the United States.
Regulatory agencies in 40 countries have approved Gardasil for use in males, but not the Food and Drug Administration, which has approved it only for females aged 9 to 26 because of the lack of evidence of efficacy in males.
Now, however, Merck plans to ask the FDA to extend approval to males. As yet, there is no evidence that the vaccine prevents HPV-related cancers in males.