Novartis has received the FDA approval for its multiple sclerosis (MS) medicine Extavia. The drug has been approved for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations. The therapy is also indicated for patients who have experienced a first clinical episode of MS and have features consistent with the disease as shown by magnetic resonance imaging.

The FDA has issued a warning for the anti-smoking drugs Chantix and Zyban as bizarre behavior, including suicide, has been seen in people taking these medicines. Both drugs will now carry “black box” labels warning informing people that those consuming these drugs should be closely watched for signs of suicidal thoughts, depression, hostility or other changes in behavior.

The European Medicines Agency has granted approval to OMRIX Biopharmaceuticals, Inc.’s liquid fibrin sealant, Evicel. The product can now be marketed in Europe for supportive therapy in surgery for hemostasis. It is currently sold in the US markets by a Johnson & Johnson division. EVICEL, with this approval, is licensed for commercialization in the 27 countries coming under the European Union. This easy and ready to use liquid does not contain aprotinin, preventing any adverse effects.

The FDA has approved a second oral rotavirus vaccine, called Rotarix, which is in liquid form and is given in a two-dose series to infants of 6 to 24 weeks of age. The rotavirus infection results in vomiting and diarrhea in children. The new vaccine provides protection against the G1, G3, G4, and G9 strains, which cause rotavirus gastroenteritis. The vaccine is manufactured by GlaxoSmithKline Biologicals, of Rixensart, Belgium.

Acomplia, the obesity drug manufactured by Sanofi-Aventis, has received a positive final appraisal determination from the National Institute for Health and Clinical Excellence (NICE) in the U.K. The body has also guided to the use of Acomplia as a support for diet and exercise in overweight patients who have not responded to other obesity agents.