Ranbaxy Labs responds to FDA action against Paonta Sahib plant
GURGAON, India Ranbaxy Labs issued a statement Wednesday afternoon in response to action that the Food and Drug Administration had taken against the company’s plant in Paonta Sahib, India.
The FDA invoked an Application Integrity Policy after finding falsified data and test results on regulatory approval applications from the plant, though the agency has found no evidence that Ranbaxy drugs on the market are substandard, and the policy does not affect the company’s other plants. The plant has been under an FDA import alert since September.
Ranbaxy said it will analyze the letter and other information and respond appropriately, and that it is continuing to cooperate with the FDA.
Heart drug Efient approved by EMEA
INDIANAPOLIS The European Medicines Agency has approved a new drug by Eli Lilly & Co. and partner Daiichi Sankyo Co. for preventing heart attacks in patients with acute coronary syndrome undergoing a heart-opening procedure, the two companies announced Monday.
The EMEA approved Efient (prasugrel) for ACS patients undergoing percutaneous coronary intervention surgery following a positive opinion adopted by the EMEA’s Committee for Medicinal Products for Human Use.
“This European approval is good news for doctors and patients since more than 700,000 people die from heart attacks in the European Union each year,” Daiichi Sankyo president and CEO Takashi Shoda said in a statement. “We believe Efient will become an important new treatment for patients with ACS undergoing PCI, a severe disease with potentially life-threatening consequences.”
The Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee voted unanimously to recommend approval of prasugrel for the United States market on Feb. 3, but the two companies had not decided on a brand name at the time.
Health care to continue growing as share of economy says new CMS report
WASHINGTON Growth in healthcare spending probably will decline by this year because of the recession, but health will continue growing as a share of the economy, according to a new report by the Centers for Medicare and Medicaid Services.
Growth in national health expenditures is expected to be 6.1% in 2008, as it increases from $2.2 trillion in 2007 to $2.4 trillion in 2008, while growth in the gross domestic product is expected to be 3.5%. For this year, healthcare spending is expected to increase by 5.5%, while the GDP is expected to decline by 0.2%. Meanwhile, the health share of the GDP is expected to increase from 16.2% in 2007 to 16.6% in 2008 and 17.6% in 2009, representing about one-third of the total increase in the health share of the GDP for 2008 through 2018.
Prescription drug spending growth is expected to slow from 4.9% in 2007 to 3.5% in 2008, as customers fill fewer prescriptions and switch to generics, but prescription drug spending growth likely will rebound to 4% in 2009.