Regulatory and Drug Approvals News

Covidien (NYSE: COV), a leading global provider of healthcare products, announced the launch of DuraSeal™ spine sealant, the first product approved by the U.S. Food and Drug Administration (FDA) for intra-operative sealing of the dural membrane during spine procedures. Nearly 1.5 million spine surgeries are performed in the U.S.

Mylan Inc. (NASDAQ: MYL) announced that its privately held Indian subsidiary, Matrix Laboratories Limited, has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed-release (DR) Capsules, 15 mg and 30 mg. This product is shipping immediately and will be sold under the Mylan Pharmaceuticals brand.

GlaxoSmithKline (GSK) announced that the US Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) for its unadjuvanted influenza A (H1N1) pandemic vaccine.

W.L. Gore & Associates (Gore) announced that it has received European CE Mark approval for the next generation GORE TAG® Thoracic Endoprosthesis. The device is available in an expanded portfolio of sizes to meet a broad range of patient needs and was engineered to treat multiple etiologies including thoracic aortic aneurysms (TAAs), traumatic aortic transections and thoracic aortic dissections.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Tap Pharmaceutical's proton pump inhibitor Prevacid® (lansoprazole) Delayed-Release Capsules, 15 mg and 30 mg. Customers will begin receiving product on November 11, 2009.

Wright Medical Group, Inc. (NASDAQ: WMGI), a global orthopaedic medical device company, announced that the United States Food and Drug Administration (FDA) has given approval to the Company to market its original CONSERVE® Plus Total Hip Resurfacing System.

The drug Sprycel, approved for use by the U.S. Food and Drug Administration in patients with chronic myeloid leukemia, significantly inhibited the growth and invasiveness of ovarian cancer cells and also promoted their death, a study by researchers with UCLA's Jonsson Comprehensive Cancer Center found.

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company,has announced the availability of INTUNIV™ (guanfacine) Extended Release Tablets in pharmacies across the United States for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents ages 6 to 17.

ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today that the U.S. Food & Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for Omapro™ (omacetaxine mepesuccinate) for the treatment of patients with chronic myeloid leukemia (CML) who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation.

The first human embryonic stem cell treatment approved by the FDA for human testing has been shown to restore limb function in rats with neck spinal cord injuries - a finding that could expand the clinical trial to include people with cervical damage. In January, the U.S. Food & Drug Administration gave Geron Corp.