FDA

Cornerstone Therapeutics Inc. (Nasdaq: CRTX) had received a Warning Letter from the Food and Drug Administration ("FDA") alleging that its Deconsal CT chewable tablets (Phenylephrine HCl 10 mg, Pyrilamine Maleate 16 mg) and Deconsal DM chewable tablets (Phenylephrine HCl 10 mg, Pyrilamine Maleate 16 mg, Dextromothorphan HBr 15 mg) are new drugs lacking an approved application and as such should not be introduced into interstate commerce. Cornerstone is preparing an appropriate response to the FDA.

Cornerstone has not sold any Deconsal CT products since July 2009 and has not sold any Deconsal DM products since January 2009. Net revenues from the sales of the Deconsal products in 2009 year to date are $173,498. Cornerstone does not intend to manufacture, or have manufactured, any further lots of this product.

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Pfizer (NYSEL PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved Geodon (ziprasidone HCI) Capsules for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. The approval is based on clinical data demonstrating that Geodon is an effective and generally well-tolerated adjunctive treatment for long-term symptom control in patients with bipolar disorder.

Geodon is also FDA-approved for the treatment of acute manic and mixed episodes associated with bipolar disorder, with or without psychotic features, and for the treatment of schizophrenia. Since the FDA approval of Geodon in February 2001, nearly 2 million adult patients have been treated with this important therapy.

Bipolar disorder, which affects approximately 5.7 million adults in the United States, is a debilitating, chronic condition that requires lifelong treatment and management. More than 90 percent of patients with bipolar disorder have recurring mood episodes, making it important to establish a long-term treatment plan to help prevent recurrence and stabilize mood. The recurrence of mood episodes associated with bipolar disorder can have a devastating impact on patients' lives, and the disease is associated with high rates of disability.

Intuitive Surgical, Inc. (Nasdaq: ISRG) announced that it has received regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) to allow marketing of its da Vinci S System in Japan.

Commenting on the announcement, Gary Guthart, President and COO of Intuitive Surgical, said, "We are pleased with the Ministry of Health's decision to grant Shonin approval for the da Vinci S Surgical System. This approval has been a long process for Intuitive, and we are happy to be one step closer to bringing our products to market in Japan. Our focus will now shift toward satisfying the trade and importation requirements necessary for commercialization and to obtain appropriate reimbursement for da Vinci procedures in Japan."

Dendreon Corporation (NASDAQ: DNDN) today announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company's amended Biologics License Application (BLA) for PROVENGE (sipuleucel-T) is a complete response. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of May 1, 2010, by which time it will respond to Dendreon's amended BLA. Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC).

The FDA considers this to be a complete, Class 2 Resubmission following the action letter the company received in 2007. The BLA includes data from the IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) trial, which was conducted under a Special Protocol Assessment agreement with the FDA. The IMPACT study met its pre-specified primary endpoint demonstrating a statistically significant improvement in overall survival in men with metastatic CRPC. The resubmission also contains the remaining information requested by the FDA pertaining to chemistry, manufacturing and controls section of the BLA for PROVENGE.

If approved by the FDA, PROVENGE would represent the first product in a new therapeutic class known as active cellular immunotherapies.

Boston Scientific Corporation (NYSE: BSX) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE Mark approval to market its WallFlex Fully Covered Esophageal Stent for the treatment of malignant esophageal strictures (obstructions) caused by tumors in patients with resectable or non-resectable esophageal cancer.

The WallFlex® Partially Covered Esophageal Stent was cleared by the FDA and received CE Mark in 2008. Both stents -- along with the complete WallFlex Stent family of self-expanding metal stents (SEMS) -- will be available for hands-on demonstration at the GASTRO 2009 conference, which is being held November 21-25 in London.