SUPPLIER NEWS — Impax Labs received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment. The drug maker said the FDA approved its 150-mg doxycycline monohydrate capsules, a drug used to treat bacterial infections and a generic version of Adoxa, made by Nycomed subsidiary PharmaDerm. The 150-mg strength of Adoxa had sales of about $25 million during the 12 months ended in December 2010, according to Wolters Kluwer.
Mylan announced the launch, through subsidiary Mylan Pharmaceuticals, of voriconazole tablets in the 50-mg and 200-mg strengths. The drug is a triazole antifungal agent. The tablets are a generic version of Pfizer’s Vfend, which had sales of $186 million in 2010, according to IMS Health. Mylan launched its version of the drug under a settlement with Pfizer. As the first company to file for FDA approval, Mylan is entitled to 180 days of market exclusivity in which to compete with Pfizer’s product.
Teva Pharmaceutical Industries has launched a generic drug for treating symptoms of menopause. The company announced the availability of Jinteli (norethindrone acetate and ethinyl estradiol) tablets. The drug is a generic version of Warner Chilcott’s FemHRT and is available in the 1-mg/5-mcg strength.
The FDA announced the approval of Corifact, used to prevent bleeding in people with the rare genetic disorder congenital Factor XIII deficiency, which affects one in 3 million to 5 million people in the United States. The drug is manufactured by Marburg, Germany-based CSL Behring.
Amicus Therapeutics announced results of a 23-patient phase-2 extension study of the investigational drug Amigal (migalastat hydrochloride), designed to improve kidney function in patients with the genetic enzyme disorder Fabry disease. The study — an extension of the original, three- to six-month, 26-patient phase-2 study — used two criteria to measure kidney function: protein in the urine during a 24-hour period and a commonly used measure called estimated glomerular filtration rate, or eGFR. Amicus said preliminary data indicated that eGFR was stable after three to four years of treatment with Amigal, while protein levels in the urine also were reduced.