The FDA has approved GlaxoSmithKline’s Lamictal XR extended-release tablets as once-a-day, add-on therapy for epilepsy in patients over 13 years of age suffering from primary generalized tonic-clonic seizures. Lamictal XR is already approved for partial onset seizures for patients in this age group.

The study depicted that the addition of Lamictal XR in therapy reduced the seizure frequency more than placebo in patients with uncontrolled primary generalized tonic-clonic seizures.

Microlife Medical Home Solutions, Inc. has announced The Biggest Loser medical staff will implement the MedGem indirect calorimeter to assess metabolic changes in program contestants. The MedGem handheld indirect calorimeter is an FDA-cleared, Class II, medical device that assesses metabolic rate by measuring a patient’s resting oxygen consumption. Resting metabolic rate varies dramatically between individuals. Until recently, most healthcare providers would estimate RMR using complicated estimation equations.

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Palomar Medical Technologies Inc. will go ahead with the commercialization of its FDA-cleared home-use laser device for treatment of periorbital wrinkles, despite the termination of its commercialization agreement with Johnson & Johnson. Palomar plans to launch the products during the second half of next year. With the agreement cancellation, JJCC avoids having to commit to the significant level of funding required to successfully launch a new product into the mass market.

The FDA has given Shire PLC reaffirmation on a prior decision to give the attention-deficit-hyperactivity disorder drug Vyvanse five years of market exclusivity. The drug was first approved in 2007 for children between 6 and 12 years old and then again in 2008 for adults. It has competition-free sales until February 23, 2012. GlaxoSmithKline’s sales force is helping in the promotion of the drug in the US.

The FDA has directed Glenmark Generics Inc and three other manufacturers to stop marketing unapproved codeine sulphate tablets in the US market. The drug is an old narcotics product widely used to treat pain. These products, marketed in 30mg and 60mg form, lack FDA approval and the agency has no evidence that they are safe and effective.

A small inhaler and insulin powder created by the MannKind Corporation is awaiting the FDA’s response for marketing purposes. After the FDA gives marketing approval for the insulin powder, called Afresa, patients can use a new, palm-size device that may let them discretely inhale a dose of insulin instead of using a needle. Afresa is inhaled into the lungs, where it dissolves and travels into the bloodstream.

Salix 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.

Theravance 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.

Shire 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).

Unichem Lab has received Abbreviated New Drug Abbreviation (ANDA) approval from the US FDA for clonidine hydrochloride tablets. Clonidine Hydrochloride is a low dose potent and popular molecule in the antihypertensive category. Clonidine hydrochloride tablets USP 0.1mg, 0.2mg and 0.3mg are therapeutically equivalent to Catapres tablets USP 0.1mg, 0.2mg and 0.3mg from Boehringer Ingelheim. Clonidine hydrochloride formulations have annual sales of roughly $334 million in the US.