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.

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.