FDA

June 22, 2009 -- WASHINGTON – U.S. Senator Tom Udall, D-N.M., today applauded President Barack Obama for signing the Family Smoking Prevention and Tobacco Control Act into law. As New Mexico Attorney General, Udall successfully sued the tobacco industry and in Congress has been a strong proponent of legislation to allow the Food and Drug Administration (FDA) to regulate tobacco products. Click here to see his speech from the Senate floor, urging passage of this bill.

“After more than a decade of fighting to protect children from tobacco,” said Udall, “I am pleased that this law paves the way for commonsense regulation of this dangerous product.”    » read more »

June 22, 2009 -- WASHINGTON- U.S. Senator Jeff Bingaman today joined President Barack Obama at a White House signing ceremony of legislation empowering the Food and Drug Administration (FDA) to regulate tobacco products. Bingaman is a member of the Senate Health, Education, Labor and Pensions Committee, which helped write the bill.

Among other things, the bipartisan legislation would give the FDA authority to make tobacco products less toxic for those who continue to use them and prevent the tobacco industry from misleading the public about the dangers of smoking. The measure also would help smokers overcome their addiction.    » read more »

June 22, 2009 -- OLYMPIA – Washington Governor Chris Gregoire released the following statement on the signing by President Obama of legislation that gives the Food and Drug Administration authority to regulate tobacco products:

“Curbing tobacco use among children and adults has been one of the driving forces of my career, going back to my days as state attorney general. I couldn’t be more pleased that President Obama signed legislation today that gives the Food and Drug Administration authority to regulate tobacco products. Given that tobacco use kills an estimated 400,000 Americans and costs the nation roughly $96 billion in health care bills each year, it is critically important that the FDA regulates tobacco in the same way it regulates nearly every other product we consume.    » read more »

Merck Statement in Response to the FDA's June 12, 2009 Communication with Updated Information on Leukotriene Inhibitors, Including SINGULAIR® (montelukast sodium)

WHITEHOUSE STATION, N.J., June 12, 2009 - Merck & Co., Inc. issued the following statement in response to today's communication from the U.S. Food & Drug Administration (FDA) addressing updated information on leukotriene inhibitors, including SINGULAIR® (montelukast sodium).    » read more »

Phase III data show rapid and sustained remission in more than 90% of Ilaris-treated patients with cryopyrin-associated periodic syndrome (CAPS)[1]

Basel, June 18, 2009 - The US Food and Drug Administration (FDA) has approved Ilaris® (canakinumab) for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS), which includes a number of rare but life-long auto-inflammatory disorders with debilitating symptoms and limited treatment options[1],[2],[3],[4]. The FDA granted priority review to Ilaris based on its potential to meet an important clinical need for patients with CAPS.    » read more »

Urges Swift Passage in House and Senate

June 17, 2009 -- Congress took a major step forward today to improve the safety of the American food supply. The House Energy and Commerce Committee unanimously approved a comprehensive bipartisan bill that, if approved by the full House and Senate, would go far toward reducing the toll of foodborne illness in the United States.

This bill, for the first time in history, specifically directs the Food and Drug Administration to take steps to prevent foodborne illness and assigns resources to begin the job. The bill would make food safety a primary focus of the FDA, not an afterthought as it has been for so long.    » read more »

June 4, 2009 -- Washington, D.C. – Today, U.S. Senator Mark Udall urged his colleagues to support bipartisan legislation designed to reduce the number of kids who get hooked on smoking, help smokers overcome their addiction, and make tobacco products less toxic.

In a speech submitted for the Congressional Record, Udall said that by preventing new smokers from becoming addicted, the Family Smoking Prevention and Tobacco Control Act being debated in the Senate this week would help lower health care costs and promote wellness – two of the biggest hurdles facing the American health care system today.    » read more »

Used for the Treatment of Mixed Dyslipidemia

June 4, 2009 -- AstraZeneca and Abbott announced today that the companies have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational compound for the treatment of mixed dyslipidemia, a combination of two or more lipid abnormalities including high LDL cholesterol (the “bad” cholesterol), high triglycerides and low HDL-cholesterol (the “good” cholesterol).    » read more »

June 3, 2009 -- WASHINGTON, DC -- In an effort to curb smoking, improve public health, and save billions of taxpayer dollars each year, the U.S. Senate is currently debating the Family Smoking Prevention and Tobacco Control Act, legislation long supported by Senator Jack Reed (D-RI) to give the Food and Drug Administration (FDA) authority to regulate tobacco products and prohibit misleading tobacco advertisements.    » read more »

Orlando FL, 29 May 2009 -- GlaxoSmithKline [NYSE: GSK] and Genmab A/S [OMX: GEN] today announced that the United States Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to three that the ARZERRA™ (ofatumumab) data are reasonably likely to predict clinical benefit for patients with chronic lymphocytic leukemia (CLL) whose disease is refractory to fludarabine and alemtuzumab. Ofatumumab is an investigational treatment.    » read more »

Approximately 22 million women in US have osteopenia, or low bone mass, putting them at increased risk of fractures of hip, spine and wrist.

Basel, June 1, 2009 - Reclast® (zoledronic acid 5 mg) Injection[*] has been approved by the US Food and Drug Administration (FDA) as the first and only therapy to prevent postmenopausal osteoporosis for two years with a single dose[1]. Reclast, or Aclasta® as it is known outside the US, is already approved in more than 80 countries including the US and EU as a once-yearly infusion for the treatment of postmenopausal osteoporosis[1],[4].    » read more »

Panel Votes in Favor of Use by Physician/Nurse Teams to Deliver Minimal-to-Moderate Propofol Sedation

(May 28, 2009) –Ethicon Endo-Surgery today announced that the Anesthesiology and Respiratory Therapy Devices Advisory Committee of the U.S. Food and Drug Administration (FDA) voted in favor of approval of the SEDASYS® System for use by physician/nurse teams to administer minimal-to-moderate propofol sedation during screening and diagnostic procedures for colorectal cancer (colonoscopy) and the upper gastrointestinal tract (EGD).

The SEDASYS® System, the first computer-assisted personalized sedation (CAPS) system, integrates drug delivery and patient monitoring to enable propofol sedation personalized to each patient’s needs.    » read more »

CORAL GABLES, FL, May 29, 2009 Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX) today announced top-line results from its U.S. Phase II clinical trial to treat cocaine addiction. The data from the trial showed that CPP-109 did not demonstrate statistical significance in the primary endpoint -- that a significantly larger proportion of CPP-109-treated subjects than placebo-treated subjects were cocaine-free during the last two weeks of the treatment period (Weeks 11 and 12). The clinical trial did not reveal any unexpected "serious" adverse events.    » read more »

Raritan, NJ (May 28, 2009) - Ortho-McNeil announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the new drug application (NDA) for rivaroxaban, an oral, once-daily anticoagulant. The NDA, filed in July 2008 by Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) on behalf of Ortho-McNeil, seeks approval to market rivaroxaban for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery.    » read more »

Washington, D.C. (May 28, 2009)—The American Lung Association joins the World Health Organization (WHO) in calling attention to the global epidemic of death and disease caused by tobacco use on World No Tobacco Day taking place on Sunday, May 31, 2009.

This year, World No Tobacco Day will focus on the urgent need for graphic health warnings to be placed on all tobacco products in order to reduce the deadly impact tobacco use has on the global community. According to the WHO, tobacco use kills 5.4 million people every year and accounts for one in 10 adult deaths worldwide. In the United States, the tobacco caused death toll ends more than 393,000 lives each year. Another 50,000 American deaths are annually attributed to secondhand smoke exposure.    » read more »