Impax gets FDA approval for Mestinon Timespan generic

HAYWARD, Calif. — Impax Laboratories has received Food and Drug Administration approval for a generic version of Mestinon Timespan (pyridostigmine bromide extended release) tablets. The drug, intended to treat myasthenia gravis, will be available in 180-mg tablets. It is the first drug to be approved following Impax’s Sept. 4 resolution of issues outlined by the FDA in a warning letter to the company.

“We are pleased to receive approval of generic Mestinon Timespan Tablets, as this is the first generic product approved from the Hayward, CA facility following the resolution of the warning letter,” Impax CEO and president Fred Wilkinson said. “Our pending pipeline of 31 Abbreviated New Drug Applications at the FDA includes 17 products developed in Hayward. Although we cannot predict the timing of subsequent approvals, we are excited about the potential opportunities within our pipeline of products from this facility.”

According to IMS Health data, in the 12 months ending July 2015, Mestinon Timespan had U.S. sales of $45 million.