FDA approves Bayer contraceptive for heavy menstrual bleeding
WAYNE, N.J. — The Food and Drug Administration has approved a drug that the manufacturer called the first oral contraceptive that also treats heavy menstrual bleeding.
Bayer HealthCare Pharmaceuticals announced Wednesday the approval of Natazia (estradiol valerate and estradiol valerate and dienogest) tablets for heavy menstrual bleeding not caused by any conditions of the uterus. The drug was originally approved as an oral contraceptive in May 2010.
"Heavy menstrual bleeding is a common disorder reported by around 3 million women of reproductive age each year in the United States," Bayer HealthCare Pharmaceuticals VP and head of U.S. medical affairs Pamela Cyrus said. "As the first oral contraceptive treatment approved for heavy menstrual bleeding in women without organic pathology who choose an [oral contraceptive] for contraception, Natazia represents a new treatment approach for appropriate women with this medical condition."
Abbott to study use of Humira in patients with hidradenitis suppurativa
ABBOTT PARK, Ill. — Abbott is set to enroll patients into two late-stage clinical trials designed to evaluate the safety and efficacy of one of its drugs as a treatment for a difficult-to-treat chronic inflammatory skin disease.
Abbott said it will start to enroll patients in two phase-3 trials — M11-313 and M11-810 — which will examine the investigational use of Humira (adalimumab) in adults with moderate to severe hidradenitis suppurativa, a disease characterized by painful, recurrent abscesses and nodules that primarily appear in the groin or under the armpits or breasts. The abscesses and nodules start out as tender, swollen bumps and over time, these lesions can fill with fluid, burst and result in scars, pain and discomfort, Abbott said.
The 36-week, multinational, randomized, double-blind, placebo-controlled studies will include approximately 600 patients with moderate to severe HS and will be conducted at approximately 50 sites worldwide, including sites in Australia, Canada, Europe and the United States.
"Ten years ago, Humira was approved for moderate to severe rheumatoid arthritis and since then has achieved five additional indications to treat millions of patients across a range of immune diseases," said John Medich, divisional VP clinical developmentof immunology at Abbott. "Abbott is committed to investigating adalimumab as a treatment option for patients with hidradenitis suppurativa, and these studies represent another important step in continuing this exploration."
Amneal launches liquid generic Lexapro
BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched a generic version of an antidepressant made by Forest Labs.
The drug maker announced the launch of escitalopram oxalate oral solution in 5-mg/5-mL strength in a peppermint flavor, the company said. The product is a therapeutically equivalent alternative to Lexapro and also marks the first generic version of the drug in liquid form on the market.
Amneal said it has begun shipping the product and is available to wholesalers, distributors, as well as directly to the trade.