April 2006 - FDA News

FDA Approvals - FDA Approves Generic Cholesterol and Leg Pain Drugs (Senior Journal)

FDA Approves Generic Cholesterol and Leg Pain Drugs (Senior Journal)
April 25, 2006 Numerous studies have shown senior citizens can save tremendous amounts of money by using generic drugs, even in the Medicare prescription drug program. The Food and Drug Administration today announced approvals for two generics that will be of interest to many older people. The first, Pravastatin, is a generic version of the cholesterol-lowering drug Pravachol. The second,

Study assesses relationship between conflicts of interest and voting patterns at FDA meetings (EurekAlert!)
Disclosures of conflicts of interest at Food and Drug Administration (FDA) drug advisory committee meetings are common, often of considerable financial value, and rarely result in the recusal of advisory committee members, but excluding those with conflicts would not have altered the overall vote outcome at any meeting, according to a study published in the April 26 issue of JAMA.

/ index (China Daily) Chinese pharmaceutical companies that want access

/ index (China Daily)
Chinese pharmaceutical companies that want access to the international market are learning how to raise their management standards from the US Food and Drug Administration (FDA), one of the world's strictest regulators.

Positive Phase II Results With Orally Active GnRH Receptor Antagonist In Endometriosis - Neurocrine Biosciences Inc (Medical News Today)
Neurocrine Biosciences,Inc. (Nasdaq: NBIX) today announced positive results of its 'proof ofconcept', safety, efficacy and dose-finding Phase II clinical trial usingits proprietary, orally-active small molecule Gonadotropin-ReleasingHormone (GnRH) receptor antagonist (NBI-56418). The 3-month data comes from a multi-center, randomized, double-blind,placebo-controlled trial involving patients with

FDA Approvals - Study assesses relationship between conflicts of interest and voting patterns

Study assesses relationship between conflicts of interest and voting patterns at FDA meetings (EurekAlert!)
Disclosures of conflicts of interest at Food and Drug Administration (FDA) drug advisory committee meetings are common, often of considerable financial value, and rarely result in the recusal of advisory committee members, but excluding those with conflicts would not have altered the overall vote outcome at any meeting, according to a study published in the April 26 issue of JAMA.

FDA Approves Genzyme's Myozyme(R) for All Patients with Pompe Disease (PR Newswire via Yahoo! Finance)
Genzyme Corp. announced today that the Food and Drug Administration has granted marketing approval for Myozyme in the United States.

C2a ? Taper? Acetabular System This device is is a

C2a ? Taper? Acetabular System
This device is is a ceramic on ceramic artificial hip replacement system, surgically implanted to completely replace a hip joint. (Approved: 12/16/2005)

Dagoba Organic Chocolate Recalls Eclipse 87%, Los Rios 68%, and

Dagoba Organic Chocolate Recalls Eclipse 87%, Los Rios 68%, and Prima Matera 100% Dark Chocolate Products Because of High Lead Levels
The products were distributed nationally through wholesale food distributors and through stores that sell organic, natural and/or specialty foods, as well as via select internet sites.

Boca Medical Products, Inc. Issues Nationwide Recall of Insulin Syringe Product
Boca Medical Products, Inc., of Coral Springs, Florida is initiating a recall of 3984 boxes of Ultilet Insulin Syringe 30g 1/2cc product lot number 5GEXI as displayed on the inner case. The product is being recalled because of possible bacterial presence of Bacillus Cereus and Staphylococcus Intermedius.

FDA Signs Arrangement With Sweden s Medical Products Agency The FDA

FDA Signs Arrangement With Sweden s Medical Products Agency
The FDA and the Medical Products Agency (MPA) of Sweden have signed a mutual Confidentiality Arrangement that allows the two Agencies to share certain non-public information, including law enforcement information and internal pre-decisional information.

FDA Approvals - FDA Approves Genzyme's Myozyme(R) for All Patients with Pompe Disease

FDA Approves Genzyme's Myozyme(R) for All Patients with Pompe Disease (PR Newswire via Yahoo! Finance)
Genzyme Corp. announced today that the Food and Drug Administration has granted marketing approval for Myozyme in the United States.

Kensey Nash Receives FDA 510(k) Clearance for New ThromCat(TM) Thrombectomy Catheter System (PR Newswire via Yahoo! Finance)
Kensey Nash Corporation today announced that it has received 510 clearance for its ThromCat Thrombectomy Catheter System from the U.S. Food and Drug Administration .

Study assesses relationship between conflicts of interest and voting patterns at FDA meetings (EurekAlert!)
Disclosures of conflicts of interest at Food and Drug Administration (FDA) drug advisory committee meetings are common, often of considerable financial value, and rarely result in the recusal of advisory committee members, but excluding those with conflicts would not have altered the overall vote outcome at any meeting, according to a study published in the April 26 issue of JAMA.

Cyberonics Announces Launch of TRD Patient Registry (PR Newswire via

Cyberonics Announces Launch of TRD Patient Registry (PR Newswire via Yahoo! Finance)
Cyberonics, Inc. today announced that 22 medical centers from across the country are actively enrolling patients in a landmark patient registry of treatment- resistant depression and Vagus Nerve Stimulation Therapy.

SRI International acquires Quality Clinical Labs (PharmaBiz)
SRI International, an independent non-profit research and development organization, has acquired Quality Clinical Labs (QCL). QCL is the only commercial laboratory of its type in California performing clinical pathology analyses in compliance with Good Laboratory Practice (GLP) regulations.

New Research From Packard Children's Hospital Experts Presented At Pediatric Academic Societies' Annual Meeting (FinanzNachrichten)
The following are among a few of the many notable presentations by physicians from Packard ( Nachrichten / Aktienkurs ) Children's Hospital at the upcoming Pediatric Academic Societies Meeting in San Francisco April 29- May 2. For more information or to reach one of the researchers, call Robert Dicks at (650) 387-7500 or email him at rdicks@lpch.org.

FDA Approvals - US Submission of Exforge(R) Accepted for Review By the FDA

US Submission of Exforge(R) Accepted for Review By the FDA as a New Therapy Option for High Blood Pressure (Market Wire via Yahoo! Finance)
Novartis announced today that the new drug application for Exforge was accepted for standard review by the US Food and Drug Administration as a new treatment option for people with high blood pressure.

Parenteral packaging concerns for biotech drugs (Pharmalicencing)
Biotechnology promises treatments and even cures for many diseases previously considered intractable. Although the biotech industry began just about a quarter-century ago, since the late 1990s the number of new biopharmaceutical approvals has nearly equaled those for new small-molecule drugs.

FDA Approvals - Many FDA Experts Have Drug Industry Ties (Health Scout) But

Many FDA Experts Have Drug Industry Ties (Health Scout)
But votes on drug approvals wouldn't change much if they withdrew from advisory panels, study finds.

Teva Receives First FDA Approval for Generic Pravachol(R); Appellate Court Denies Apotex Request for Injunctive Relief (RedNova)
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S.

Conflicts of Interest, Voting Patterns at FDA Drug Advisory Committee Meetings (Newswise)
Disclosures of conflicts of interest at Food and Drug Administration (FDA) drug advisory committee meetings are common, often of considerable financial value, and rarely result in the recusal of advisory committee members, but excluding those with conflicts would not have altered the overall vote outcome at any meeting.

Investigation of Serious Eye Infections Associated With Soft Contact Lens

Investigation of Serious Eye Infections Associated With Soft Contact Lens Use and Contact Lens Solution
The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are alerting health care professionals and their patients who wear soft contact lenses to an increasing number of reports in the United States of rare but serious fungal infections in the eye that can cause permanent loss of sight.

Hemispherx Biopharma Announces Retention of New Senior Personnel and Contractors

Hemispherx Biopharma Announces Retention of New Senior Personnel and Contractors Ahead of Key NDA Filing for Chronic (Business Wire via Yahoo! Finance)
PHILADELPHIA----April 25, 2006--Hemispherx Biopharma, Inc. today announced that it has retained a team of scientists and executives with unique experience in immunology, pharma manufacturing, and regulatory compliance to help the Company prepare for the filing of a new drug application for the experimental immunostimulant Ampligen , developed for the potential treatment of Chronic Fatigue

FDA Approvals - Teva Receives First FDA Approval for Generic Pravachol(R); Appellate Court

Teva Receives First FDA Approval for Generic Pravachol(R); Appellate Court Denies Apotex Request for Injunctive Relief (RedNova)
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S.

FDA finds dozens new deficiencies at Andrx (Sun-Sentinel)
Food and Drug Administration inspectors have uncovered more than two dozen new manufacturing deficiencies at Andrx Corp.'s generic drug plant in Davie, according to an agency report released Monday.

Many FDA Experts Have Drug Industry Ties (Health Scout)
But votes on drug approvals wouldn't change much if they withdrew from advisory panels, study finds.

VISTAKON (senofilcon A) Contact Lens VISTAKON (senofilcon A) is a

VISTAKON (senofilcon A) Contact Lens
VISTAKON (senofilcon A) is a soft contact lens made of approximately 38% water and 62% senofilcon A (a silicone-containing hydrogel). It is available in spherical, toric, multifocal, and multifocal-toric designs. (Approved: 12/20/2005)

North Country Spring Water, Ltd. Recalls Entire Production of Bottled

North Country Spring Water, Ltd. Recalls Entire Production of Bottled Water Products Due to Potential Health Concerns
North Country Spring Water, Ltd. bottled water products were distributed wholesale in New York , Vermont and New Jersey where the bottled water was sold to consumers through retail stores and direct delivery.

Pinnacle Foods Group Inc. Issues Allergy Alert on Brownie Mix
These cartons may contain 'Walnut Brownie' mix rather than the 'Double Fudge Brownie' mix and could therefore contain nuts not listed on the carton.

Boca Medical Products, Inc. Issues Nationwide Recall of Insulin Syringe Product
Boca Medical Products, Inc., of Coral Springs, Florida is initiating a recall of 3984 boxes of Ultilet Insulin Syringe 30g 1/2cc product lot number 5GEXI as displayed on the inner case. The product is being recalled because of possible bacterial presence of Bacillus Cereus and Staphylococcus Intermedius.

FDA Approvals - Light Sciences Oncology files $86.25M IPO (BizJournals) Light Sciences Oncology,

Light Sciences Oncology files $86.25M IPO (BizJournals)
Light Sciences Oncology, a Snoqualmie cancer treatment company that was spun off from its parent last year, has filed plans for an $86.25 million initial public offering.

Cephalon, Inc. Provides Update on Regulatory Status of SPARLON(TM) (FinanzNachrichten)
FRAZER, Pa., April 24 /PRNewswire-FirstCall/ -- Cephalon, ( Nachrichten ) Inc. announced today that the United States Food and Drug Administration (FDA) has extended the action date for its review of the Supplemental New Drug Application for SPARLON(TM) (modafinil) Tablets [C-IV] for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents to August 22, 2006.

FDA Approves First Generic Pravastatin Pravastatin is indicated for the

FDA Approves First Generic Pravastatin
Pravastatin is indicated for the treatment of individuals with high cholesterol levels (hyperlipidemia) or who are at increased risk for atherosclerosis-related cardiac and cardiovascular events, such as heart attack and stroke in which high cholesterol levels are a factor.

Shire Receives Interim Response From FDA on ADDERALL XR(r) Citizen

Shire Receives Interim Response From FDA on ADDERALL XR(r) Citizen Petition (PR Newswire via Yahoo! Finance)
Shire plc announces that on April 20, 2006 it received correspondence from the United States Food and Drug Administration informing Shire that the FDA has not yet resolved the issues raised in Shire's pending ADDERALL XR Citizen Petition.

FDA Approvals - Pharma s One-Hit Wonders (Red Herring) Are VCs betting the farm

Pharma s One-Hit Wonders (Red Herring)
Are VCs betting the farm on one horse?

Advancis Pharmaceutical Provides Update on Additional Keflex Products (PR Newswire via Yahoo! Finance)
Advancis Pharmaceutical Corporation , a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced that the U.S. Food and Drug Administration has informed the Company that its review of the supplemental New Drug Application for additional Keflex products is still ongoing.

Gen-Probe Exercises Option to Develop Novel Platform for Rapid Molecular Testing, Purchases Minority Interest in (PR Newswire via Yahoo! Finance)
Gen-Probe Incorporated has exercised its option to develop a novel nucleic acid testing platform based on Qualigen's patented, FDA-approved FastPack immunoassay system, the companies announced today.

FDA Approvals - ThermoGenesis Reports at AmSECT Perfusionist Conference Successful Production of Activated

ThermoGenesis Reports at AmSECT Perfusionist Conference Successful Production of Activated Thrombin From Patient's (PR Newswire via Yahoo! Finance)
ThermoGenesis Corp. today announced that research data on a new processing disposable that produces thrombin from whole blood in the operating room was presented yesterday at the American Society of Extra-Corporeal Technology 44th Annual International Conference taking place April 19-22 in Las Vegas, Nevada.

Pharma s One-Hit Wonders (Red Herring)
Are VCs betting the farm on one horse?

Advancis Pharmaceutical Provides Update on Additional Keflex Products (PR Newswire via Yahoo! Finance)
Advancis Pharmaceutical Corporation , a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced that the U.S. Food and Drug Administration has informed the Company that its review of the supplemental New Drug Application for additional Keflex products is still ongoing.