PHARMACY

FDA investigates Lupin’s drug manufacturing plant in India

BY Alaric DeArment

NEW DELHI, India Not long after it began investigating manufacturing problems with Indian generic drug maker Ranbaxy, the Food and Drug Administration has begun scrutinizing Lupin.

The agency said it found 15 manufacturing deficiencies at the company’s plant in Madhya Pradesh following an inspection of the plant that ended Wednesday.

The FDA banned imports of several drugs from Ranbaxy in September after finding manufacturing problems at two of Ranbaxy’s plants in India.

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FDA approves Mylan’s generic drug for treating epilepsy

BY Alaric DeArment

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.

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Study shows Gardasil is effective in prevention of HPV in males

BY Alaric DeArment

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.

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