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Weekly Drug News Round Up - January 16, 2013

Santarus Receives Approval of Uceris for Induction of Remission in Ulcerative Colitis

Uceris utilizes a proprietary multi-matrix system colonic delivery technology Read More...

The U.S. Food and Drug Administration (FDA) has approved Uceris (budesonide) extended-release tablets for the induction of remission in adult patients with active, mild to moderate ulcerative colitis. Uceris contains the oral corticosteroid budesonide, and the dose is one 9 milligram tablet taken orally once daily in the morning for up to 8 weeks. Patients should not eat grapefruit or drink grapefruit juice while taking Uceris because this can lead to increased blood levels of Uceris. Uceris is manufactured by Santarus, Inc. and it is expected the drug will be commercially available in March 2013.

Skyla IUD Approved to Prevent Pregnancy for Up to Three Years

Skyla is the first, new IUD on the market in 12 years Read More...

Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg, a new hormone-releasing system that is placed in the uterus for the prevention of pregnancy for up to three years, has been approved by the U.S. Food and Drug Administration (FDA). Skyla, manufactured by Bayer Healthcare Pharmaceuticals is more than 99 percent effective at preventing pregnancy and can be used by women whether or not they have had children. New research suggests that long-term birth control options, such as intrauterine devices (IUDs) and under-the-skin implants, are 20 times more effective for preventing pregnancy than birth control pills, patches and rings.

Drug Safety Communication: Lowered Doses for Zolpidem

FDA recommends that the zolpidem bedtime dose be lowered due to impaired morning alertness  Read More...

FDA is notifying the public of new information about zolpidem, a commonly prescribed insomnia drug. FDA recommends that the bedtime dose be lowered because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. Women appear to be more susceptible to this risk because they eliminate zolpidem from their bodies more slowly than men. This announcement focuses on the brand name products Ambien, Ambien CR, Edluar, and Zolpimist and available generics. Data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs (Ambien CR and generics).

Sporadic Shortages of Flu Vaccine and Tamiflu Are on the Rise

All adults and children at least 6 months old should receive a flu vaccination each year, and it’s not too late Read More...

Flu season typically peaks in January or February but can extend as late as May. This flu season is turning out to be more severe than last year's. Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration (FDA) has said that local shortages of the flu vaccine and Tamiflu (oseltamivir) oral suspension, the flu treatment and preventive have been reported. FDA-approved instructions on the Tamiflu label provide compounding directions for pharmacists who need to make a liquid form of Tamiflu from Tamiflu capsules. And it’s not too late to get a flu vaccine. If you need one, ask your pharmacist or doctor.

Will Lance Armstrong’s Doping Confession Uncover Anything New?

Previous USADA allegations claim the doping was orchestrated by the seven-time Tour de France winner Armstrong Read More...

According to sources from USA Today, American cyclist Lance Armstrong admitted that he began using performance-enhancing drugs in the mid-1990s, before he was diagnosed with cancer. According to reports, Armstrong will make a confession on Thursday night during his interview on the Oprah Winfrey Network (OWN) of using doping practices in cycling, but the details will be held back. The source also revealed that Armstrong and his representatives have had discussions with the U.S. Anti-Doping Agency (USADA) about a future meeting. In October 2012 the USADA made public the details of the use of performance-enhancing drugs by the US Postal Service Pro Cycling (USPS) Team.