Rosen Quoted on FDA Requirements for Drug Shelf Life

Partner David Rosen was quoted in a Modern Healthcare article, “Extending EpiPen Shelf Life Could be a Relief for Patients, Costly for Mylan,” on September 22, 2016. The article discussed Mylan’s announcement to extend the shelf life of its EpiPen, currently the pricey devices must be replaced nearly every year. Rosen commented on the Food and Drug Administration regulations required to request an expiration date change, and said if the company’s data is solid, the process is pretty straightforward and objective. He continued and said the company may have changed its manufacturing process or it may be using some kind of chemical stabilizer in its epinephrine solution to prevent oxidation and lower its sensitivity to heat.