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.

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.

Germany’s Merck KGaA filed for approval of its multiple sclerosis (MS) pill cladribine in the US in a bid to bring the first oral treatment against the debilitating disease to market. The company has submitted a New Drug Application (NDA) with the FDA two months after regulatory filing in Europe. The move follows a pivotal Phase III clinical trial, which showed in January that cladribine reduced the number of relapses per year in patients with some forms of MS by 58 percent compared with a placebo.

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.

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.

Amag Pharmaceuticals has received clearance from the FDA to sell its iron deficiency drug in the US market. The intravenous drug, feromoxytol, will be marketed under the brand name Feraheme for adult patients suffering from anemia with chronic kidney disease. The company expects the drug tobe available for commercial use during the second half of July.

Covidien announced the launch of Permacol™ Biologic Implant, a biologic mesh for hernia repair. The implant joins Covidien’s line of products as a result of acquisition of Tissue Science Laboratories by the company. It will be available in the American and  European markets in 2009. Containing improved porcine collagen, Permacol™ Biologic Implant brings together the clinical benefits of a biologic and a synthetic’s intra-operative efficiency. The hydrated and ready-to-use product can be cut or shaped as required, providing a suitable soft tissue repair.

The U.S. Food and Drug Administration has classified Physio-Control, Inc.’s medical device recall of 249 fully automatic LIFEPAK CR Plus automated external defibrillators (AEDs) as a Class I action. Some of these devices manufactured between May 2004 and April 2007 are configured incorrectly. The shock button can not be located as it is covered in the fully automated device. This may lead to a delay in delivery of therapy as a patient complained. Physio-Control has notified replacement devices at no charge to all the affected customers.

GlaxoSmithKline PLC has launched a new treatment for Parkinson’s disease (PD) in the U.K. ReQuip XL® (ropinirole prolonged-release tablets) is the U.K.’s first and only once-daily non-ergot oral dopamine agonist available for the treatment of PD1, providing continuous delivery of ropinirole from a single daily dose. Ropinirole prolonged-release is approved for the treatment of idiopathic Parkinson’s disease (Monotherapy and Adjunct Therapy) in patients already taking ropinirole immediate release tablets and in whom adequate symptomatic control has been established.