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)

Wyeth’s pharmaceuticals division said that on May 21 the FDA issued an approvable letter for its experimental postmenopausal osteoporosis treatment Viviant. However, the FDA has requested Wyeth to submit additional information, along the same lines as the agency's December 2007 approvable letter issued for Viviant’s NDA. The FDA request includes further assessment of stroke and venous thrombotic event incidence, plus additional source documents, while highlighting specific data collection and reporting issues

Swiss biotech group Basilea Pharmaceutica AG said the US Food and Drug Administration has issued an approvable letter for Ceftobiprole for the treatment of complicated skin and skin structure infections including diabetic foot infections.The letter indicates that the ceftobiprole application is approvable, subject to completion and assessment of clinical study site inspections.

La Food and Drug Administration decidió extender hasta el 10 de mayo de este año la revisión de la droga que desarrollan Adolor y GlaxoSmithKline, Entereg (Alvimopan), indicada para disfunciones intestinales provocadas por sustancias opioides en pacientes no oncológicos (ileo postoperatorio). El fármaco ya recibió en el 2006 un carta de aprobación. Detalles.