Watson gets FDA approval for generic Yasmin
MORRISTOWN, N.J. The Food and Drug Administration has approved a generic oral contraceptive made by Watson Pharmaceuticals, the drug maker said Tuesday.
Watson announced the FDA’s approval of Zarah (drospirenone and ethinyl estradiol tablets) in the 3 mg/0.03 mg strength. The drug is a generic version of Bayer’s Yasmin.
Watson said it has started shipping the drug, though Bayer’s patent litigation suit against the company concerning the drug remains pending in the U.S. District Court for the Southern District of New York.
Yasmin and generic versions had sales of around $97 million during the 12 months ended in June, according to IMS Health.
CMS chief Berwick is driving hard to spur health innovation, report says
WASHINGTON The recently installed head of the federal Medicare program is pushing hard to promote new and more cost-effective ways to treat patients and improve the nation’s health scorecard.
On Monday, The Boston Globe reported that Donald Berwick, tapped by President Obama in July as administrator of the Centers for Medicare and Medicaid Services, is working to expand health-innovation projects around the country in line with the massive health-reform law enacted earlier this year. Berwick envisions as many as 300 test sites devoted to developing new, integrated models of patient care by physician groups and other health professionals, according to The Globe.
Spurring those innovative pilot projects will be billions of dollars allocated by the health-reform bill for a health innovation center, and for the development of health information technology to eliminate waste and promote better decision-making among doctors, pharmacists and other health providers.
To that end, Medicare will designate provider groups participating in the innovation pilot projects as “accountable care organizations’’ under the program, the newspaper reported. The underlying goal: to replace the costly and increasingly unwieldy fee-for-service model that now dominates such public health programs as Medicare and Medicaid, with “global payments” that reward healthier patient outcomes and coordinated care among physicians and other providers, according to The Globe.
Berwick, the report noted, is a strong advocate for experimentation in new, outcomes-based models of patient care, and is working to double the size of the innovation center and promote its involvement in new healthcare demonstration projects. Test sites for new collaborative care models will be up and running by the end of 2011, The Globe reported.
Silenor now available by prescription
SAN DIEGO Drug maker Somaxon Pharmaceuticals has made its treatment for insomnia available by prescription, the company said Tuesday.
Somaxon announced the availability of Silenor (doxepin), which received approval from the Food and Drug Administration in March as a treatment for insomnia characterized by difficulty with sleep maintenance.
“The commercial availability of Silenor, the first and only prescription product approved for the treatment of sleep maintenance insomnia that is not a controlled substance, is an important milestone for Somaxon and marks the completion of our product launch preparations,” Somaxon president and CEO Richard Pascoe said.
The company will promote the drug to healthcare providers along with Procter & Gamble.