The Food and Drug Administration delivered AstraZeneca Plc. a complete response letter for Axanum drug (Esomeprazole-Nexium + low doses of aspirin) to prevent ulcers of the stomach and duodenum.

Brystol-Myers Squibb Co. announced that the Food and Drug Administration delivered a complete response letter for Belatacept, previously known as BMS 224818. The drug is indicated to prevent kidney transplant rejection. The FDA requested additional information (no clinical trials) to finally approve the biological product.

Salix Pharmaceuticals Ltd. received a Food and Drug Administration complete response letter for Giazo (Balzalazide) drug, for the treatment of mildly to moderately active ulcerative colitis in patients older than 18 years.

Seattle, Washington-based biopharmaceutical company Cell Therapeutics Inc. experimental drug, Pixuvri (Pixantrone), received a Food and Drug Administration complete response letter, at the same time it will have to provide an additional clinical study in order to obtain final approval. The drug is indicated to treat refractory aggressive non-Hodgkin’s lymphoma in patients that do not respond to other options.

The Food and Drug Administration delivered a complete response letter to Abbott Laboratories Inc. and AstraZeneca Plc. regarding documentation filed for cholesterol drug approval Certriad (Rosuvastatin+Fenofibric Acid) a combination of blockbuster drugs Crestor and TriLipix.

U.S. biotechnology Company Cephalon Inc. announced that the Food and Drug Administration delivered a complete response letter for Nuvigil (Armodafini) to treat Jet Lag syndrome. The reasons for FDA initial rejection are related to the quality of some of the data used to seek approval.

The Food and Drug Administration delivered a complete response letter to biotechnology ViroPharma Inc. a new indication for Cynrize.

The Food and Drug Administration sent a complete response letter to Johnson & Johnson y Bayer AG on venous thromboembolism drug Xarelto (Rivaroxaban) for patients subject to hip or knee-replacement surgery. Both companies stated that the regulators office did not request any additional studies to approve the product.

Johnson & Johnson said U.S. regulators issued a Complete Response letter on the company´s experimental psoriasis monoclonal antibody ustekinumab (Stelara), meaning the drug will not get FDA OK until they receive certain risk-mitigation information.

AMAG Pharmaceuticals Inc said the Food and Drug Administration has accepted additional data filed on its anemia drug candidate ferumoxytol. The U.S health regulators has set December 30 as a target action date to complete the review of the drug

Discovery Laboratories Inc. announced that the Food and Drug Administration has accepted for review its Complete Response for Surfaxin (lucinactant) for the prevention of respiratory distress syndrome in premature infants. The Warrington, Pennsylvania-based company received Approvable Letter for Surfaxin in May 2008, which did not call for any additional clinical trials.

AMAG Pharmaceuticals Inc reported it received a complete response letter from the Food and Drug Administration regarding the marketing application for its anemia candidate Ferumoxytol. AMAG said it believes it can address the issues raised without additional clinical trials. The complete response letter is sent when drugs do not yet met the health regulators criteria for approval, replacing the approvable and non-approvable letters.

The Food and Drug Administration (FDA) have requested more information on Roche Holding AG´s rheumatoid arthritis drug Actemra (toclizumab), the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. Roche said no additional studies needed to be conducted as a pre-requisite for approval of the drug

Gilead Sciences Inc said it received a complete response letter from the U.S. Food and Drug Administration (FDA) for its NDA (new drug application) for aztreonam lysine for inhalation, its experimental treatment for cystic fibrosis, in which the FDA also requests an additional clinical study for approving the drug with orphan designation.

Encysive Pharmaceuticals Inc. announced that it has received a written response from the U.S. Food and Drug Administration (FDA) regarding Encysive´s request for formal dispute resolution on its New Drug Application (NDA) for Thelin (sitaxsentan sodium) for the treatment of pulmonary arterial hypertension (PAH). The FDA issued a fourth “approvable letter,” requesting the company for further trials.

Johnson & Johnson (J&J) reported that the U.S. Food and Drug Administration have requested further information on the company´s New Drug Application (NDA) for their drug Doribax, submitted in June 2007 for hospital-acquired pneumonia. The drug had been approved in October 2007 for complicated intra-abdominal and urinary tract infections.

Indevus shares slumped 68 percent following the FDA´s request for more safety data before approving its 3-monthly injectable testosterone preparation Nebido. Indevu, hard hit by the agency’s decision, plans to conduct another safety study and re-apply for approval. Indevus’s treatment of male hypogonadism is not expected to hit the markets soon

Swedish specialty pharma company Meda said the FDA has requested more information on its NDA for azelastine hydrochloride nasal spray in a new formulation. Meda will contact the regulatory agency to clarify the request. This will put off the approval of Meda’s new formulation of Astelin, one of its key products

Wyeth said the FDA has requested more safety and effectiveness data of its broad spectrum antibiotic Tygacil for the treatment of community-acquired pneumonia (CAP)