Archive for September, 2009

Salix Pharma gets FDA approval for Metozolv

SalixSalix Pharmaceuticals Ltd has received the FDA approval for the marketing of a fast-dissolving drug called Metozolv intended for treating diabetic gastroparesis and heartburn. The FDA’s approval covers 5 mg and 10 mg tablets of Metozolv ODT. The drug’s main ingredient, metoclopramide, has long been used to treat the two conditions in different forms. Diabetic gastroparesis is a condition in which the stomach takes too long to clear out food.

New style of breast implant close to the FDA approval

Breast Implant“410B,” a new style of breast implant, could reduce healing time and ease pain. Although it is not yet approved by the FDA, the plastic surgeon who created it calls it the “most studied breast implant ever.” Also known as the ‘Gummy Bear Implant,’ the product is the only implant in history that stimulated the development of techniques that let people recover in 24 hours and go out for dinner on the night of surgery, Plastic Surgeon John Tebbetts said proudly.

Telavancin receives approval from the FDA

TheravanceTheravance Inc and partner Astella Pharma won the FDA approval for their superbug-fighting drug telavancin. The drug will hit the market in the fourth quarter as a treatment for adults with complicated skin and skin structure infections caused by methicillin-resistant Staphylococcus aureus, commonly known as the superbug MRSA and other Gram-positive bacteria. The drug is the first approved specifically to target MRSA, which currently is treated largely with the antibiotic vancomycin.

FDA approves INTUNIV

ShireShire has received approval from the FDA for INTUNIV (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. The once-daily INTUNIV drug is expected to be available in the US pharmacies by November and will come in four dosage strengths (1 mg, 2 mg, 3 mg, and 4 mg).