FDA approves Wockhardt epilepsy drug
PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic epilepsy drug made by Wockhardt, the company said.
Wockhardt, based in India, announced the approval of lamotrigine extended-release tablets in the 25-mg, 50-mg, 100-mg, 200-mg and 300-mg strengths.
The drug is a generic version of GlaxoSmithKline’s Lamictal XR. The U.S. market for the drug is about $250 million, according to IMS Health.
FDA approves Bayer IUD
WAYNE, N.J. — The Food and Drug Administration has approved a new intrauterine device for preventing pregnancy made by Bayer HealthCare Pharmaceuticals, the drug maker said.
Bayer announced the approval of Skyla (levonorgestrel-releasing uterine system), which can prevent pregnancy for up to three years. The IUD contains 13.5 mg of levonorgestrel.
Nearly 50% of pregnancies in the United States are unintended, according to the National Center for Health Statistics.
FDA calls for lower dosage in some insomnia drugs
SILVER SPRING, Md. — The Food and Drug Administration is ordering the makers of several sleep drugs to lower the recommended dosage due to the risk that they can impair patients the morning after, the agency said Thursday.
The FDA announced that it was requiring the manufacturers of drugs containing the active ingredient zolpidem to lower the current recommended dosage in light of new data showing that the morning after use, the drug can remain in the blood in sufficient quantities to impair activities that require alertness, such as driving.
According to the agency’s recommendation, the dosage for women should be lowered from 10 mg to 5 mg for immediate-release drugs and from 12.5 mg to 6.25 mg for extended-release formulations. For men, doctors should consider prescribing these lower doses, the FDA said. The higher and lower doses are both currently available on the market.
"To decrease the potential risk of impairment with all insomnia drugs, healthcare professionals should prescribe, and patients should take, the lowest dose capable of treating the patient’s insomnia," FDA Office of Drug Evaluation I director Ellis Unger said. "Patients who must drive in the morning or perform some other activity requiring full alertness should talk to their healthcare professional about whether their sleep medicine is appropriate."
Zolpidem is the active ingredient of Sanofi’s Ambien and Ambien CR, Meda Pharmaceuticals’ Edluar and NovaDel Pharma’s Zolpimist, as well as several generics.