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Thursday, 06/18/2015 6:01:14 PM

Thursday, June 18, 2015 6:01:14 PM

Post# of 38634
Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that the United States Food and Drug Administration ("FDA") has indicated that the Company's tentatively-approved strengths of its generic Focalin XR® (dexmethylphenidate hydrochloride extended-release) capsules (the "Product") will have to meet newly-imposed conditions for bioequivalence prior to receiving final approval. The strengths affected are 5 mg, 10 mg, 20 mg and 40 mg. The already-approved 15 mg and 30 mg strengths now in the market are not affected.

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.