FDA review of pain drug Remoxy’s tamper-proofing yields mixed conclusions
ROCKVILLE, Md. A panel of officials from the Food and Drug Administration said Pain Therapeutics’ drug Remoxy had less likelihood of being abused than other painkillers, but also stated that the manufacturer didn’t show that the drug’s anti-tampering technology would prevent abuse.
The drug is a long-acting formulation of oxycodone that comes in a special gelatin capsule that precludes the methods drug addicts employ when using oxycodone to get high. Most oxycodone drugs come in tablets, which addicts can crush and then inject or snort.
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.