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Content about U.S. Food and Drug Administration

03.22.10
Galderma Laboratories' Differin Lotion receives FDA approval

Galderma Laboratories, L.P. today announced the U.S. Food and Drug Administration approval of Differin® (adapalene) Lotion, 0.1%, the first-ever lotion formulation of the well-tolerated retinoid adapalene, for the treatment of acne. Differin Lotion, 0.1% will be available by prescription in April 2010.

03.19.10
FDA Issues Final Rule Restricting Access And Marketing Of Cigarettes And Smokeless Tobacco Products To Youth

The U.S. Food and Drug Administration issued a final rule containing a broad set of federal requirements designed to significantly curb access to and the appeal of cigarettes and smokeless tobacco products to children and adolescents in the United States. Published March 19, 2010, the new rule becomes effective June 22, 2010, and has the force and effect of law...

03.19.10
Global Partners Join Forces To Speed Development Of New TB Drug Combinations

Ahead of World TB Day, US Food and Drug Administration Commissioner Margaret Hamburg helped public and private sector partners launch a new collaboration to significantly accelerate the development of combination treatments for tuberculosis and replace an almost 50-year-old drug regimen...

03.19.10
Somaxon Announces FDA Approval Of Silenor(R) (doxepin) For The Treatment Of Insomnia

Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia characterized by difficulty with sleep maintenance...

03.15.10
FDA Announces New Boxed Warning On Plavix

The U.S. Food and Drug Administration added a boxed warning to the anti-blood clotting drug Plavix (clopidogrel), alerting patients and health care professionals that the drug can be less effective in people who cannot metabolize the drug to convert it to its active form...

03.15.10
FDA Announces New Boxed Warning On Plavix

The U.S. Food and Drug Administration added a boxed warning to the anti-blood clotting drug Plavix (clopidogrel), alerting patients and health care professionals that the drug can be less effective in people who cannot metabolize the drug to convert it to its active form...

03.14.10
FDA Task Force Seeks Public Comments On Increasing Transparency With Regulated Industry

As part of the final phase of its transparency initiative, the U.S. Food and Drug Administration is seeking comment from the public and other interested stakeholders on how the agency can increase transparency in its interactions with regulated industry. Posted in the March 12, 2010, Federal Register, the request for electronic or written comments has a deadline of April 12, 2010.

03.12.10
FDA Approves Boston Scientific's Express(R) LD Iliac Stent System

Boston Scientific Corporation (NYSE: BSX) today announced that the U.S. Food and Drug Administration (FDA) has approved its Express® LD Iliac Premounted Stent System for use in iliac arteries. The Express LD Iliac Stent is the first and only low-profile, premounted, balloon-expandable stent approved by the FDA for use in treating iliac artery disease...

03.11.10
Boston Scientific's Express LD Iliac Premounted Stent System for use in iliac arteries receives FDA approval

Boston Scientific Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved its Express® LD Iliac Premounted Stent System for use in iliac arteries. The Express LD Iliac Stent is the first and only low-profile, premounted, balloon-expandable stent approved by the FDA for use in treating iliac artery disease. The Company said it plans to launch the product immediately in the United States.

03.11.10
Eisai's Dacogen five-day dosing regimen for treatment of MDS receives FDA approval

Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a five-day dosing regimen for Dacogen® (decitabine) for Injection to treat patients with myelodysplastic syndromes (MDS), a group of bone marrow diseases that alter the production of functional blood cells.

03.10.10
DSPA's lurasidone NDA accepted for FDA review

Dainippon Sumitomo Pharma America, Inc., a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd., today announced that the U.S. Food and Drug Administration recently accepted for review the lurasidone New Drug Application (NDA) for the treatment of patients with acute schizophrenia. The NDA was submitted to FDA on December 30, 2009 and will receive a standard review.

03.09.10
FDA's Advisory Committee votes 9-3 to recommend approval of Esbriet for treatment of patients with IPF

InterMune, Inc. announced today that the U.S. Food and Drug Administration's Pulmonary-Allergy Drugs Advisory Committee voted 9-3 to recommend approval of Esbriet® (pirfenidone) for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function.

03.03.10
FDA Advisory Committee Recommends Approval Of Belatacept

Bristol-Myers Squibb Company (NYSE:BMY) announced that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee has voted 13 to 5 to recommend approval of belatacept, a selective co-stimulation blocker, for the prophylaxis of acute rejection in de novo kidney transplant patients...

02.24.10
FDA recommends H1N1 for inclusion in next year's flu vaccine

The U.S. Food and Drug Administration (FDA) on Monday recommended that the H1N1 (swine flu) strain be added to next year's seasonal flu vaccine, "putting an end to separate shots deployed against the pandemic," Bloomberg reports. The FDA committee voted unanimously to make the H1N1 strain one of the three strains included in the shot, according to the news service. "The panel's recommendations are routinely adopted and used to guide vaccine manufacturers," Bloomberg writes (Randall, 2/22).

02.20.10
GlaxoSmithKline And XenoPort Receive FDA Complete Response Letter For Horizant™ (GSK1838262/XP13512) For RLS

GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) Wednesday received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Horizant™(gabapentin enacarbil) Extended-Release Tablets, an investigational non-dopaminergic treatment for moderate-to-severe primary Restless Legs Syndrome (RLS)...

02.11.10
Daiichi Sankyo's Benicar receives FDA approval for hypertension treatment in children and adolescents aged 6-16

Daiichi Sankyo, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the hypertension treatment Benicar® (olmesartan medoxomil) for use in children and adolescents 6 to 16 years of age. Benicar was originally approved in 2002 for the treatment of hypertension in adults.

02.10.10
Medical Radiation Exposure Safeguards Should Be Tighter Says FDA

The US Food and Drug Administration (FDA) says safeguards for avoiding unnecessary exposure to medical radiation should be tightened and announced a new three-pronged initiative on Tuesday to increase oversight of the biggest contributors: computed tomography (CT), nuclear medicine studies, and fluoroscopy...

02.03.10
FDA approves Xiaflex drug for treatment of Dupuytren's contracture

The U.S. Food and Drug Administration (FDA) has approved Xiaflex, a new drug to treat Dupuytren's contracture (or disease) that was discovered and developed by Marie A. Badalamente, Ph.D., and Lawrence C. Hurst, M.D., in the Department of Orthopaedics at Stony Brook University Medical Center.

02.02.10
Pervasis Therapeutics Receives FDA Clearance For Pivotal Phase 3 Trial Of Vascugel(R)

Pervasis Therapeutics, Inc. announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on the design of a pivotal Phase 3 clinical trial for Vascugel®, an investigational new drug for the prevention of hemodialysis access graft failure. The agreement was made under the FDA's Special Protocol Assessment (SPA) procedure...

01.07.10
BioVex's Phase 3 melanoma study amended to include first line patients

BioVex Inc, a company developing new generation biologics for the treatment of cancer and prevention of infectious disease, announced today that the U.S. Food and Drug Administration (FDA) has agreed that BioVex's ongoing OPTiM clinical study in unresectable Stage IIIb-IV melanoma be amended to include untreated (i.e., first line) patients as well as previously treated patients as defined in the original protocol.