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Monday, 02/23/2015 9:48:43 AM

Monday, February 23, 2015 9:48:43 AM

Post# of 38634
we received a conditional approval from the U.S Food and Drug Administration ("FDA") to launch our generic Focalin XR® 5 mg capsules. It is understood by the Company that the conditional approval could be made final upon the expiry of six months from the date of marketplace launch in the United States by the Company first to file for approval of the 5 mg strength with the FDA. We believe that Teva Pharmaceuticals USA, Inc. ("Teva") is the Company with that first-to-file exclusivity status. Should we receive final approval to launch the 5mg strength of our generic Focalin XR ® capsules six months after the date of launch of the 5 mg strength by Teva, we believe that Par, our manufacturing, marketing and distribution partner for our generic Focalin XR ® products intends to launch this strength immediately upon the expiry of the exclusivity period in May 2015, but there can be no assurance as to when or if any launch will occur.

May should be good. Hopefully they're ready to launch immediately..

Looks like Regabatin XR will be around December 30, 2018
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