FDA News

FDA approves Inlyta to treat patients with a type of

Thu, 09 Feb 2012 21:45:14 +0000

FDA approves Inlyta to treat patients with a type of advanced kidney cancer
The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.

FDA: Do not use ShoulderFlex Massager The U.S. Food and

Thu, 09 Feb 2012 21:00:09 +0000

FDA: Do not use ShoulderFlex Massager
The U.S. Food and Drug Administration is warning consumers again not to use the ShoulderFlex Massager, imported by King International and sold by various companies, due to serious potential health risks.

FDA Approvals - Mylan Receives Final FDA Approval for First Generic Version of

Thu, 09 Feb 2012 20:55:03 +0000

Mylan Receives Final FDA Approval for First Generic Version of Doryx Tablets, 150 mg
PITTSBURGH, Feb. 9, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL - News) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) ...

Device firms, FDA reach deal on new product OKs
The medical device industry agreed to pay the FDA $595 million, which is to be used to accelerate the review process.

Reviewing the drug class of 2011
The drug class of 2011 was larger than the past few graduating classes. We count over 30 new innovative drugs found among the list of FDA approvals last year. This is in contrast to the 20-something range of the past few years. On the list are some clear breakthrough treatments and a few glimpses of the future of biotech . The specific drugs are listed further below, but first a big picture ...

Merit Medical Systems Receives FDA Warning Letter Regarding Merit Laureate(R)

Thu, 09 Feb 2012 20:00:08 +0000

Merit Medical Systems Receives FDA Warning Letter Regarding Merit Laureate(R) Hydrophilic Guidewire
SOUTH JORDAN, Utah -- Merit Medical Systems, Inc. , a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced it received ...

FDA grants priority review to Salix treatment
Salix Pharmaceuticals Ltd. said Tuesday that the Food and Drug Administration granted a priority review to its potential treatment for HIV-associated diarrhea.The Raleigh, N.C., company had submitted the ...

Former FDA Senior Official Michael Chappell Joins Greenleaf Health LLC
Greenleaf Health LLC today announced that Michael Chappell, former Acting Associate Commissioner for Regulatory Affairs at the Food and Drug Administration , has joined the firm as Senior Advisor.

FDA Approvals - Reviewing the drug class of 2011The drug class of 2011

Wed, 08 Feb 2012 23:50:06 +0000

Reviewing the drug class of 2011
The drug class of 2011 was larger than the past few graduating classes. We count over 30 new innovative drugs found among the list of FDA approvals last year. This is in contrast to the 20-something range of the past few years. On the list are some clear breakthrough treatments and a few glimpses of the future of biotech . The specific drugs are listed further below, but first a big picture ...

FDA Approves KALYDECO (Ivacaftor), The First Medicine To Treat The Underlying Cause Of Cystic Fibrosis
Vertex Pharmaceuticals Incorporated announced recently that the U.S. Food and Drug Administration (FDA) has approved KALYDECOTM (ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF), a rare, genetic disease.

Ironwood Announces FDA Advisory Committee Meeting Will Not Be Scheduled in Connection with New Drug Application for ...
Ironwood Pharmaceuticals, Inc. announced that it was informed this evening that the U.S. Food and Drug Administration will not schedule an advisory committee meeting in connection with the its review of the New Drug Application for linaclotide proposed for the treatment of irritable bowel syndrome with constipation and chronic constipation .

FDA Approvals - Reviewing the drug class of 2011The drug class of 2011

Wed, 08 Feb 2012 03:55:04 +0000

FDA approves Kalydeco to treat rare form of cystic fibrosis

Tue, 07 Feb 2012 22:00:10 +0000

FDA approves Kalydeco to treat rare form of cystic fibrosis
The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.

Ohio orangutan gets newer birth control deviceA Cleveland Clinic women's

Tue, 07 Feb 2012 21:50:04 +0000

Ohio orangutan gets newer birth control device
A Cleveland Clinic women's health specialist has made a house call at the zoo to demonstrate how to fit an orangutan with a newer brand of implanted birth-control device.

Ohio orangutan 1st in US with birth control device
An orangutan at a Cleveland zoo has become the first such animal in North America to receive an implanted birth control device.

FDA completes work on three drug user fee programs The

Tue, 07 Feb 2012 21:45:06 +0000

FDA completes work on three drug user fee programs
The U.S. Food and Drug Administration has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients, FDA Commissioner Margaret A. Hamburg, M.D. said today. The recommendations were transmitted to Congress today by Health and Human Services Secretary Kathleen Sebelius.

Elecsys Anti-HBc IgM Immunoassay and Elecsys PreciControl Anti-HBc IgM on

Tue, 07 Feb 2012 21:20:09 +0000

Elecsys Anti-HBc IgM Immunoassay and Elecsys PreciControl Anti-HBc IgM on the cobas e 601 analyzer
The Elecsys Anti-HBc IgM Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis B virus (HBV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. (Approved: 10/26/2011)

Walgreen Co. Voluntarily Recalls Certain Lots of 13 Oz. Chocolate-Covered

Tue, 07 Feb 2012 21:10:06 +0000

Walgreen Co. Voluntarily Recalls Certain Lots of 13 Oz. Chocolate-Covered Raisins As Product May Contain Peanuts, Almonds, Soy Due to Packaging Error
Walgreen Co. is voluntarily recalling certain lots of 13-oz. Walgreens Chocolate-Covered Raisins because the packages may contain Walgreens Bridge Mix with peanut, almond and soy ingredients. The error occurred when Walgreens Bridge Mix was mistakenly packaged with the Walgreens Chocolate-Covered Raisin labeling.

President Global Corporation Announces Bin-Bin Snow Rice Crackers and Bin-Bin Rice Crackers Recall For Undeclared Egg
President Global Corp., Buena Park, CA is recalling all codes of Bin-Bin Snow Rice Cracker net weight 5.3oz (150g) and Bin-Bin Rice Crackers net weight 15.8oz (450g) because of undeclared egg allergens.

FDA and industry reach agreement in principle on medical device

Tue, 07 Feb 2012 20:55:06 +0000

FDA and industry reach agreement in principle on medical device user fees
The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.

FDA grants priority review to Salix treatmentRALEIGH, N.C. (AP)

Tue, 07 Feb 2012 20:00:12 +0000

FDA grants priority review to Salix treatment
RALEIGH, N.C. (AP) Salix Pharmaceuticals Ltd. said Tuesday that the Food and Drug Administration granted a priority review to its potential treatment for HIV-associated diarrhea.

Merit Medical Systems Receives FDA Warning Letter Regarding Merit Laureate(R) Hydrophilic Guidewire
SOUTH JORDAN, Utah -- Merit Medical Systems, Inc. , a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced it received ...

FDA: OJ from 5 nations has safe fungicide levels
WASHINGTON (Reuters) - Samples of imported orange juice from five countries were found to contain safe levels of the fungicide carbendazim, U.S. regulators said on Friday, but they made no mention of samples from Brazil, which accounts for about half of all U.S. imports. The Food and Drug Administration said that 26 of the 45 samples it had taken since testing began on January 4 were "awaiting ...

FDA Approvals - Elastomer Technology provides grip even in wet conditions.Use of Wet

Tue, 07 Feb 2012 08:45:05 +0000

Elastomer Technology provides grip even in wet conditions.
Use of Wet Grip elastomer technology, offered under THERMOLAST W trade name, increases coefficient of friction (COF) in TPE materials for greater degree of grip in dry and wet applications without any negative impact on physical and rheological performance. Wet Grip compounds, which are available in 25-60 Shore A hardness and meet FDA approvals, also enhance surface smoothness, sealing, bonding ...

2011 FDA Biopharmaceutical Approvals: Low Number And Economic Impact, But A Record Number Of Orphan Approvals And Many ...
The latest annual study of FDA biopharmaceutical product approvals by the Biotechnology Information Institute (BII) reports significant advances in health care, particularly approvals for new and orphan indications, but an overall low number of approvals and industry and economic impact.

FDA Approvals - Elastomer Technology provides grip even in wet conditions.Use of Wet

Mon, 06 Feb 2012 12:40:09 +0000

Elastomer Technology provides grip even in wet conditions.
Use of Wet Grip elastomer technology, offered under THERMOLAST W trade name, increases coefficient of friction (COF) in TPE materials for greater degree of grip in dry and wet applications without any negative impact on physical and rheological performance. Wet Grip compounds, which are available in 25-60 Shore A hardness and meet FDA approvals, also enhance surface smoothness, sealing, bonding ...

Reviewing the drug class of 2011
The drug class of 2011 was larger than the past few graduating classes. We count over 30 new innovative drugs found among the list of FDA approvals last year. This is in contrast to the 20-something range of the past few years. On the list are some clear breakthrough treatments and a few glimpses of the future of biotech . The specific drugs are listed further below, but first a big picture ...

Democrats Want to Let FDA Block Devices Tied to Recalls
U.S. regulators should be able to block medical devices based on past products with safety issues, said House Democrats, citing injuries from transvaginal implants like those made by Johnson & Johnson and C.R. Bard Inc.