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Thursday, June 18, 2015 6:01:14 PM
The FDA, in November 2013, had previously granted the Company tentative approvals for the 5 mg, 10 mg, 20 mg, and 40 mg strengths of its generic Focalin XR®. The Company is now required by the FDA to demonstrate bioequivalence with Focalin XR®, under the new bioequivalence criteria, for the 40 mg strength as a basis for the approval of each of the affected strengths.
The Company, together with its United States commercialization partner, Par Pharmaceutical, Inc., intends to review and vigorously pursue all reasonable courses of action towards achieving final approval for each of the affected strengths. There can be no assurance that the affected strengths of the Product will be granted final FDA approval or sold commercially.
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