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17 Sep 2015

Impax receives FDA approval for generic version of Mestinon Timespan Tablets, 180 mg

First generic product approved from Hayward manufacturing facility following recent resolution of Warning Letter

Impax Laboratories has announced that FDA has approved generic Mestinon Timespan Tablets (pyridostigmine bromide extended release), 180 mg. The company is in the final stages of preparing for commercialization of this product through Impax's generic division.

Fred Wilkinson, President and CEO of Impax stated: "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 on 4 September 2015. 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."

Mestinon Timespan Tablets is indicated for the treatment of myasthenia gravis. According to IMS Health (NSP), US sales of Mestinon Timespan Tablets, 180 mg were approximately $45 million for the 12 months ended July 2015.

Mestinon and Timespan are registered trademarks of Valeant Pharmaceuticals International.

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