PHARMACY

Oral contraceptive Emoquette wins FDA approval

BY Alaric DeArment

HUNTSVILLE, Ala. — A subsidiary of Endo Pharmaceuticals has won approval from the Food and Drug Administration for an oral contraceptive.

Qualitest Pharmaceuticals announced Friday the approval of Emoquette (desogestrel and ethinyl estradiol) tablets in the 0.15-mg/0.03-mg strength.

The drug is a generic version of Johnson & Johnson’s Ortho-Cept.

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FDA: Topiramate could pose birth defects risk

BY Alaric DeArment

SILVER SPRING, Md. — Pregnant mothers taking a common drug for treating epilepsy may be putting their babies at risk, according to a new report from the Food and Drug Administration.

The FDA said Friday that the drug topiramate could increase the risk for such birth defects as cleft palate and cleft lip when used by expectant mothers. Johnson & Johnson markets the drug under the name Topamax, and it is available in generic form.

“Healthcare professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age,” FDA Division of Neurology Products director Russell Katz said. “Alternative medications that have a lower risk of birth defects should be considered.”

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FDA lifts liver injury risk boxed warning from Gilead’s Letairis

BY Allison Cerra

FOSTER CITY, Calif. — Gilead on Friday announced that the Food and Drug Administration has removed a boxed warning about a possible liver injury risk caused by the drug maker’s hypertension treatment.

Gilead said the FDA approved a change to the prescribing information for Letairis (ambrisentan 5-mg and 10-mg tablets), the company’s once-daily treatment of pulmonary arterial hypertension.

The announcement followed the FDA’s review of post-marketing data, which found that during 12-week controlled clinical trials, the incidence of liver function abnormalities was 0% on Letairis and 2.3% on placebo among patients. In conjunction with this label update, PAH patients receiving Letairis no longer are required to obtain monthly liver function tests.

Gilead did note, however, that the drug will continue to carry a boxed warning, since it is contraindicated in pregnancy.

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