After file this week for EMEA approval, Human Genome Sciences Inc. sent Benlysta (Belimumab) for FDA approval. The drug is indicated to treat systemic lupus erythematosus

The Food and Drug Administration requested biotech Chelsea Therapeutics International Ltd. to delay a mid-stage trial of its experimental arthritis drug CH 4501 and sought additional details from the drug's preclinical studies, data requested should not require additional studies.

According to a Merck KGaA statement, Cladibrine drug was submitted for new FDA approval. The drug is indicated to treat multiple sclerosis.

Onyx Pharmaceuticals Inc. submitted for 2010 FDA approval of experimental drug Carfilzomib, indicated to treat severely ill multiple myeloma patients.The drug was developed jointly with Proteolix Inc. recently acquired by Onyx.

Perrigo Co. announced that the Food and Drug Administration cleared J&J generic version and over-the- counter vaginal cream, Monistat.

Johnson & Johnson said they plan to submit to the Food and Drug Administration almost 80 new medical devices and diagnostic products between 2010 and 2012.

An expert panel will review by mid September 2010, if they recommend or not, Arena Pharmaceuticals Inc. drug Lorcaserin, indicated for weight loss. Final review will be end of October.

The Food and Drug Administration accepted documentation filed by Orexigen Therapeutics Inc. regarding its obesity drug Contrave (Naltrexone SR + Bupropion SR).

FDA officials said at a meeting, prior to the one set for June 2nd., and assured that AstraZeneca´s drug Motavizumab, indicated to treat children´s respiratory syncytial virus (RSV) could lead to severe allergic reactions.

Avanir Pharmaceuticals Inc. announced that the Food and Drug Administration will review Zenvia within the next six months. The drug is a combination of Dextromethorphan + Quinidine, indicated to treat Pseudobulbar Disorder in six months.

The Food and Drug Administration cleared GlaxoSmithKline to sell Rotarix Vaccine (Rotavirus Vaccine Live Oral). The vaccine was suspended last March 22Nd. After detecting traces of porcine circovirus 1, or PCV-1. Last May 6th. Merck & Co. detected traces of porcine circovirus in their RotaTeq vaccine (Rotavirus Vaccine Live Oral Pentavalent)

A Food and Drug Administration expert panel voted a non approval recommendation for experimental NicOx SA drug Naproxcinod (Nitronaproxen) to treat arthritis.

According to an Amylin Pharmaceuticals Inc. and Alkermes Inc. the Food and Drug Administration will reconsider, the once-weekly drug Bydureon (Exenatide for Extended-Release Injectable Suspension), to treat diabetes II, by the end of October 2010. The drug is a once-weekly version of GLP 1Byetta, and will be marketed by Eli Lilly & Co.

According to Reuters, the Food and Drug Administration announced that traces of DNA pig virus were found in Merck & Co. RotaTeq vaccines (Rotavirus Vaccine Live Oral Pentavalent). Past March 22nd., the regulators agency detected a similar DNA virus in GlaxoSmithKline Plc., Rotarix vaccine (Rotavirus Vaccine Live Oral) and suggested immediate suspension.

Roche Holding AG said they will submit during this year for FDA approval, their experimental breast cancer drug TDM 1. The product combines Trastuzumab (Herceptin T) and chemotherapy (DM1) to treat breast cancer.

Previous to the The Food and Drug Administration advisory panel meeting, the regulators office stated that Nycomed A/S drug, Daxas (roflumilast) to treat patients with chronic obstructive pulmonary disease (COPD), offers a slight improvement in lung function, but comment upon the psychiatric severe side effects associated with the drug.

The Food and Drug Administration announced they will begin implementing a requirement that device manufacturers will have to provide information on pediatric patients that suffer the condition disease or condition that the device is intended to treat, diagnose, or cure, even if the device is intended for adult use.

Biotechnology Company Vivus Inc. announced that a Food and Drug Administration advisory committee will tentatively review recommendation or not for diet pill Qnexa (Phentamine + Topiramate) as soon as July 15th.

According to the Wall Street Journal, the Food and Drug Administration Commissioner, Andrew von Eschenbach, will leave the agency on Jan. 20, the day Barack Obama becomes president. Steve Nissen, Joshua Sharfstein and Janet Woodcock, named as potential candidates.

The Food and Drug Administration posted on its website a Warning Letter sent to Shionogi & Co. about misleading the public with exaggerated claims for the antibiotic Cedax (ceftibuten). According to the FDA, Shinogi claim that the drug had excellent tolerability.