FDA said this week that it is restricting the use of codeine and tramadol medicines in children. The drug’s labels will now include a contraindication that codeine should not be used to treat pain or cough, and that tramadol should not be used to treat pain, in children younger than 12 years.
FDA recently approved deutetrabenazine (Austedo, Teva Pharmaceuticals) to treat chorea associated with Huntington’s disease (HD). The medication is only the second product approved to treat HD, and is the first deuterated product approved by FDA.
Two recent studies demonstrate that pirfenidone (Esbriet, Genentech) prolongs life expectancy by 2.47 years for IPF patients and that Esbriet and nintedanib (Ofev, Boehringer Ingelheim) reduce the decline in lung function.
Meridian Medical Technologies, Mylan's manufacturing partner for the EpiPen Auto-Injector, expanded a voluntary recall of the EpiPen and EpiPen Jr. epinephrine auto-Injectors to now include additional lots distributed in the United States and other markets.
FDA approved safinamide (Xadago, Newron Pharmaceuticals) tablets as an add-on treatment for patients with Parkinson’s disease. FDA also approved new treatments for classical Hodgkin lymphoma and pemphigus vulgaris, a rare, life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.