FDA grants Endo Pharmaceuticals approval for new Opana strengths
CHADDS FORD, Pa. Endo Pharmaceuticals Holdings has received approval from the Food and Drug Administration for three new strengths of its pain drug Opana ER, according to the Associated Press.
The new dosages are: 7.5 mg, 15 mg, and 30 mg. The doses will be available on April 1.
Cowen analyst Ian Sanderson has said that Opana sales in 2008 in the U.S. should be $140 million and by 2012, it could hit $420 million based on hoped that the drug captures a 6 percent share of the opioid market.
Rx program more expensive than chain store prescriptions
DENVER Rx Outreach, a Colorado program aimed at helping low-income people afford drugs for chronic diseases, was found to be more expensive for purchasing drugs than regular chain-store pharmacies.
A 90-day supply from a choice of 110 generics costs about $20 each, and three-dozen other drugs sell for $30 and $40. In contrast, Kmart’s program for a choice of 300 generic medications for a 90-day supply retails for $15, while Costco sells their prescriptions for about $10.66 and Walgreens sells them for about $12.99.
The program, Colorado Cares Rx, was unveiled this month by the Department of Health Care Policy and financing in partnership with Rx Outreach. The program was started by the state to develop a low-cost drug program, but the sponsors are finding it harder to compete with chain store rivals, based on pricing.
Officials claim growing pains, however. Rep. Alice Madden, D-Boulder, said “This is just a first step. We have to do more.”
FDA approves Abilify for teens
TOKYO and PRINCETON, N.J. The Food and Drug Administration has approved the Otsuka Pharmaceuticals and Bristol-Myers Squibb drug application for Abilify for the acute treatment of manic and mixed episodes associated with bipolar I disorder, with or without psychotic features in pediatric patients aged 10 to 17.
The approval is based on the results of a four-week study that compared Abilify to a placebo in treating pediatric patients with bipolar disorder I. Otsuka Pharmaceuticals sponsored the study.
“We are pleased that the FDA has approved Abilify to treat pediatric patients aged 10 to 17 years suffering from Bipolar I Disorder,” said Taro Iwamoto, Ph.D., chief executive officer, president and chief operating officer, Otsuka Pharmaceutical development and c commercialization. “The approval of this new indication for ABILIFY provides clinicians with expanded treatment options that can help address the therapeutic needs of this population.”