Medical Animation Drug Approval

FDA Prevents Two Dairies From Adulterating Animal Drugs And Food
The U.S. Food and Drug Administration announced today that the District Court for the District of New Mexico has enjoined Do-Rene and Clover Knolls Dairies and their owners, Douglas B. Handley and Irene Handley, from adulterating new animal drugs and introducing adulterated food into commerce. Both companies are based in Clovis, N.M. FDA has cited the defendants on multiple occasions, most recently following inspections of the dairies from June 24 to July 1, 2008.

Pharmaceutical Companies Seek Clarity On Evidence Needed For Drug Label Change
With the discovery of a growing number of predictive biomarkers for existing drugs, the question of when and how to add pharmacogenetic information to drug labels has taken on greater urgency. On December 16 the Oncologic Drug Advisory Committee (ODAC) of the Food and Drug Administration (FDA) met in Gaithersburg, MD with representatives from pharmaceutical companies Amgen and Imclone.

MHRA - Brief Summary Of Reclassifications That Have Been Approved In The Past 12 Months, UK
Please see the relevant entry in List C (consolidated list of substances present in authorised products which have been reclassified since 1 April 2002) for full details.

FDA Approves Most Comprehensive System To Test Donated Blood For HIV, Hepatitis B & Hepatitis C
The United States Food & Drug Administration (FDA) approved a new nucleic acid test from Roche to screen donated blood for HIV-1 Group M RNA, hepatitis C RNA and hepatitis B DNA in a single, automated assay. The test, called the cobas TaqScreen MPX Test for use on the cobas s 201 system, is a qualitative in vitro test for comprehensive single-assay detection of HIV-1 Group M RNA, HIV-1 Group O RNA, HIV-2 RNA, hepatitis C Virus RNA and hepatitis B Virus DNA in human plasma.

Schering-Plough Announces European Submission Of Fertility Medicine Corifollitropin Alfa
Schering-Plough Corp., (NYSE: SGP), a leading provider of fertility treatments, announced today that the European Medicines Agency (EMEA) has validated (accepted for review) its Marketing Authorization Application (MAA) for corifollitropin alfa, the company's experimental, sustained follicle stimulant (SFS). This application will follow the Centralized Procedure.

Mild-to-moderate Active Ulcerative Colitis - Salix Receives FDA Complete Response Letter For Balsalazide Tablet
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for balsalazide tablet studied as a treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older.

FDA Issues Complete Response Letter To Ipsen For Dysport® Biologics License Application For Treatment Of Cervical Dystonia
Ipsen (Paris:IPN) today announced that the US Food and Drug Administration (FDA) issued a Complete Response Letter for its Biologics License Application (BLA) for its Botulinum toxin Type A, Dysport®. The application, submitted by the Group in late 2007, seeks approval to market Dysport® for the treatment of cervical dystonia. The Group is now actively preparing to launch the product, once approved by the FDA, and as soon as reimbursement coverage is adequate.

FDA Approves Drug For Patients With Advanced Prostate Cancer
The U.S. Food and Drug Administration recently approved the injectable drug degarelix, the first new drug in several years for prostate cancer. Degarelix is intended to treat patients with advanced prostate cancer. It belongs to a class of agents called gonadotropin releasing hormone (GnRH) receptor inhibitors. These agents slow the growth and progression of prostate cancer by suppressing testosterone, which plays an important role in the continued growth of prostate cancer.

Pegloticase BLA Filing Accepted For Priority Review By FDA
Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's Biologics License Application (BLA) for pegloticase, a novel biological drug for treatment-failure gout (TFG) patients. The FDA also granted the Company's BLA with a priority review status which accelerates the review period to six months.

X-GEN Pharmaceuticals Receives FDA Approval For AcetaZOLAMIDE For Injection USP
X-GEN Pharmaceuticals announced that it will begin marketing Acetazolamide for Injection USP. The product is AP rated and equivalent to Diamox(R)(1) by Duramed Pharmaceuticals.

Updated Labelling For Diabetes Drug Actos And Risk Of Heart Failure, Canada
Health Canada is informing diabetic patients taking Actos (the brand name for the prescription drug pioglitazone hydrochloride) of recent changes to the prescribing information for this product. Health Canada has worked with the manufacturer to strengthen the labelling around heart failure and emphasize proper use.

FDA Approves First Imaging Agent To Enhance Scans Of Blood Flow - Helps Detect Possible Blood Vessel Problems
The U.S. Food and Drug Administration today approved Vasovist Injection (gadofosveset trisodium), the first contrast imaging agent for use in patients undergoing magnetic resonance angiography, or MRA, a minimally invasive test for examining blood vessels.

FDA Warns Consumers About Tainted Weight Loss Pills - Agency Seeks Recall Of Products That Pose Serious Health Risks
The U.S. Food and Drug Administration is alerting consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk.

AVI BioPharma Announces FDA Clears IND Applications For Clinical Trials Of RNA Therapeutic Agents For Treatment Of Ebola And Marburg Viruses
AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based drugs, announced that it learned earlier today that it has received verbal clearance from the United States Food and Drug Administration (FDA) for the Investigational New Drug (IND) applications filed in November for its two lead products for Marburg and Ebola viruses. AVI BioPharma expects to receive written confirmation of the IND clearances from the FDA in early 2009.

Teva Announces Tentative Approval Of Generic Seroquel® Tablets
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of AstraZeneca's antipsychotic agent Seroquel® (Quetiapine Fumarate) Tablets, Eq. 25 mg base, 50 mg base, 100 mg base, 150 mg base, 200 mg base, 300 mg base and 400 mg base. The brand product had annual sales of approximately $3.