PHARMACY

FDA approves drug for pain during sex due to menopause

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for postmenopausal women who experience pain during sex.

The agency announced the approval of Shionogi’s Osphena (ospemifene) for women with moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause associated with declining levels of estrogen hormones.

"Dyspareunia is among the problems most frequently reported by postmenopausal women," FDA Office of Drug Evaluation III deputy director Victoria Kusiak said. "Osphena provides an additional treatment option for women seeking relief."

 

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Ranbaxy resumes production of cholesterol drug ingredients

BY Alaric DeArment

NEW YORK — Drug maker Ranbaxy Labs has started producing the ingredients for a cholesterol drug while working with the Food and Drug Administration to fix manufacturing issues that led to the recall in November 2012 of several batches of the drug.

The Indian drug maker said it had initiated corrective and preventive actions, or CAPA, as it prepared to resume supplies of generic atorvastatin calcium tablets to the U.S. market. The drug is a generic version of Pfizer’s Lipitor, and Ranbaxy became the first company to market a generic version in November 2011.

The company voluntarily recalled more than three dozen lots of the drug in November 2012, including 500-pill bottles of the drug in the 10-mg, 20-mg and 40-mg strengths, though the recall did not affect the drug in the 80-mg strength. The recall was due to the possible presence of small glass particles in the drug, the company said.

 

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Reports: Elan not responding to acquisition offer from Royalty Pharma

BY Alaric DeArment

NEW YORK — A privately owned drug maker in New York is offering $6.5 billion for Irish drug maker Elan, but hasn’t heard back from it, according to published reports.

The Associated Press reported that Royalty Pharma’s $11-per-share offer for Elan represented a 4% premium over its closing price Friday. Royalty buys royalty interests in drug products that are in late-stage development or have already entered the market, but doesn’t develop or market drugs of its own, the AP reported.

Earlier this month, Elan announced that it would sell rights to the multiple sclerosis drug Tysabri (natalizumab) to partnering company Biogen Idec for $3.25 billion plus royalties.

 

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