The U.S. District Court of New Jersey accepted Sanofi-Aventis SA arguments and blocked sales of Dr. Reddy´s Laboratories Ltd. generic version of allergic blockbuster drug Allegra.

U.S biotech Targanta Therapeutics Corp said that health regulators declined to approve oritavancin, an antibiotic the treatment of complicated skin and skin structure infections (cSSSI). According to the Food and Drug Administration, Targanta’s application did not show safety or efficacy of the drug.

The Food and Drug Administration (FDA) sent Cardiome Pharma Corp an “approvable letter” for the Canadian drugmaker´s experimental drug Kynapid, designed for treating short-term atrial fibrillation, asking for additional safety information. The news caused Cardiome shares to drop about 24 percent. Further details.

Schering-Plough announced the FDA denied approval of its anesthesia drug Bridion. An FDA advisory panel had voted unanimously to recommend the drug designed to reverse the effects of anesthesia last March, while analysts hailed it as the first major pharmaceutical advance in the field of anesthesia in two decades

The Food and Drug Administration (FDA) has not granted approval to Belgium´s UCB drug Vimpat (lacosamide), submitted as a treatment for diabetic neuropathic pain in adults. UCB to seek clarification from the FDA. The drug is a potential blockbuster, according to the company. Further details.

The FDA has turned thumbs down on Vanda’s key experimental atypical antipsychotic iloperidone, designed for the treatment of schizophrenia, stating that the drug is similar to older ones already on the market, including J&J’s Riperdal. Biotech firm shares stumbled on the news

Merck & Co announced the FDA has not approved the use of Gardasil, its blockbuster vaccines for HPV prevention, in women between 27 and 45 years of age. The company had filed a sBLA for Gardasil for this indication in January

Medicines Co announced that the Food and Drug Administration (FDA) has declined to approve an additional dosing regimen for its anti-clotting drug Angiomax in the treatment of acute coronary syndromes. The news plunged the company shares down as much as 8 percent. Further details.

The FDA sent a non approvable letter for Merck´s new compound designed to raise HDL cholesterol. Merck shares plunge as early Cordaptive promise fades

Joint-venture partners Schering-Plough Corp and Merck & Co announced the U.S. Food and Drug Administration (FDA) rejected their proposed asthma-allergy drug that would have combined two best-selling drugs, Claritin and Singulair, into one tablet. The reasons for the non-approval were not reported. Further details.

The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has decided that Genta Inc.’s clinical data in its new drug application (NDA) for refractory chronic lymphocytic leukemia (CLL) injection treatment Genasense has insufficient data to support approval. The CDER decision was in response to an appeal filed by Genta in October 2007. CDER concluded that at present there was insufficient "confirmatory evidence" in the New Drug Application (NDA) to approve the drug.

The Food and Drug Administration (FDA) sent a not approvable letter to Eli Lilly’s application to market a once-a month injectable version of its top-seller Zyprexa, which will be losing its patent protection in three years time. Wall Street market reacts, pushing Eli Lilly stock down nearly two percent. Full story.