Regulatory and Drug Approvals News

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against William F. Nickle of North East, Md., for allegedly selling veal calves for human consumption that contained illegal drug residues in edible tissues. The complaint, filed Nov. 13, 2009, in the U.S.

The U.S. Food and Drug Administration completed a coordinated, weeklong, international effort, called the International Internet Week of Action (IIWA), intended to curb illegal actions involving medical products.

Sandra Eskin, director of the Pew Health Group's Food Safety Campaign, has issued the following statement regarding the markup of the FDA Food Safety Modernization Act by the Senate Health, Education, Labor, & Pensions Committee: "The Pew Health Group applauds the members of the Senate Health, Education, Labor, & Pensions (HELP) Committee for approving the FDA Food Safety Modernization Act (S.

The European Medicines Agency has been formally notified by Otsuka Pharmaceutical Europe Ltd of its decision to withdraw its application for an extension of indication for the centrally authorised medicine Abilify (aripiprazole) tablets, orodispersible tablets and oral solution.

Spineology Inc., developer and manufacturer of minimally invasive spinal surgery devices, announced today that it has received FDA clearance for its minimally invasive surgery (MIS) Capture™ Facet Screw System. The Capture System was developed by Spineology in mid-2009 under the direction of Dr. Chet Sutterlin, product development consultant.

Guided Therapy Systems, LLC (GTS), a leading medical technology company, is the first company in the world to develop and commercialize products that employ a unique form of ultrasound technology, Intense Therapeutic Ultrasound (ITU).

Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) announced today that the U.S.

Pfizer Inc (NYSE:PFE) announced today that the U.S.

Patients should avoid using the stomach acid reducer Prilosec/Prilosec OTC (omeprazole) with the anti-clotting drug Plavix (clopidogrel), the U.S. Food and Drug Administration warned on Nov. 17. New data suggest that when patients take both Prilosec and Plavix, Plavix's ability to block platelet aggregation (anti-clotting effect) may be reduced by about half.

On Nov. 16, 2009, Judge Marvin J. Garbis of the United States District Court for the District of Maryland entered a Consent Decree of Permanent Injunction (Decree) against Old Carolina Farm and its owner, Francis Roderick, of Ijamsville, Md.