The FDA told Merck it will need to provide additional data to the agency before it can approve Emend, an experimental injectable drug for nausea caused by chemotherapy. Merck said in a statement that it is working to provide the information requested and plans to submit the data within the next few months. Once a response to the approvable letter has been submitted, FDA review of the application is targeted to be approximately six months from submission of the response, per current FDA policy, Merck said.
Schwarz Pharma announced that the FDA has approved Neupro
(rotigotine transdermal system) for the treatment of the signs and symptoms
of early-stage idiopathic Parkinson’s disease.
Dey announced that the FDA has approved its New Drug Application for Perforomist (formoterol fumarate) inhalation solution for long-term, twice-daily maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD). Formoterol is a rapid and long-lasting beta-2 agonist that has been previously approved in the US as a dry powder formulation. The molecule has 20 years of worldwide use. Perforomist inhalation solution is the first and only FDA-approved nebulized formoterol fumarate. Nebulizers convert liquid medication into a mist that patients inhale through a mouthpiece or face mask.