FDA adds approved use for Shire’s Vyvanse
SILVER SPRING, Md. — The Food and Drug Administration announced that it has expanded the approved uses of Vyvanse (lisdexamfetamine dimesylate) to treat binge-eating disorder in adults, making it the first FDA-approved medicine to treat this condition.
Patients with binge-eating disorder experience bouts of compulsive overeating, consuming larger amounts of food than what is normal. Patients also experience the sense that they lack control, the agency stated. Patients with the disorder will eat when they're not hungry — often to the point of being uncomfortably full.
“Binge eating can cause serious health problems and difficulties with work, home, and social life,” said Mitchell Mathis, M.D., director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research. “The approval of Vyvanse provides physicians and patients with an effective option to help curb episodes of binge eating.”
Vyvanse — marketed by Shire U.S. — received FDA approval in 2007 as a once-daily medication to treat attention deficit hyperactivity disorder in patients ages 6 years and older. Because of the drug's high potential for abuse, it is categorized as a schedule II controlled substance.
Mylan expands women’s healthcare portfolio with Famy Care acquisition
PITTSBURGH and MUMBAI, India — Mylan announced that it will acquire certain businesses from specialty women's healthcare company Famy Care Limited for $750 million, with additional contingent payments of up to $50 million.
Famy Care is a global leader in generic oral contaceptive products and its acquisition by Mylan makes it a leader in the hormonal contraceptives market, Mylan said. The transaction is expected to close in the second half of 2015.
"In 2008, Mylan established a partnership with Famy Care, significantly enhancing its presence in the women's health care segment in the United States and other developed country markets. With today's acquisition, we are building on this successful partnership and further accelerating our global growth in this important therapeutic area," said Mylan CEO Heather Bresch.
The transaction will complement the company's pending acquisition of Abbot's non-U.S. developed markets specialty and branded generics business, which also contains a women's healthcare portfolio.
"By adding this vertically integrated business and globalizing our women's healthcare platform, we are creating the right foundation to become a leader in this growing, attractive sector. Famy Care brings us a broad portfolio, strong technical capabilities and dedicated hormone manufacturing, which complement Mylan's powerful global commercial footprint and supply chain infrastructure," said Mylan president Rajiv Malik.
Prezcobix from Janssen Therapeutics granted FDA approval
TITUSVILLE, N,J. — Janssen Therapeutics on Thursday announced that the Food and Drug Administration has approved its Prezcobix (darunavir 800 mg/cobicistat 150 mg) tablets. The drug is used to treat human immunodeficiency virus in combination with other antiretovirals for treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions, according to the company.
The once-daily, fixed-dose Prezcobix contains 800 mg of darunavir — marketed as Prezista in the United States — and 150 mg of cobicistat, which is a pharmockinetic enhancer (sometimes referred to as a "boosting" agent) that is developed and marketed as Tybost by Gilead Sciences.
“Additional options remain an important medical priority to meet the diverse needs of those living with and managing this disease,” said Karen Tashima, M.D., professor of medicine in the division of infectious diseases, Brown University, director of HIV Clinical Studies, Miriam Hospital, and a lead investigator in the GS-US-216-0130 study. “This approval gives physicians the option of a darunavir-based fixed-dose combination tablet to treat adults living with the HIV-1 infection, which can help reduce the number of pills in their overall treatment regimen.”
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