Intellipharmaceutics International Inc., a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today advised that the United States Food and Drug Administration (“FDA”) has indicated to the Company that it has rescinded its previous requirement that the Company meet newly-imposed conditions for bioequivalence prior to receiving final approval for the Company’s tentatively-approved strengths of its generic Focalin XR.
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®. Subsequently, the Company announced in a press release dated June 18, 2015, that the FDA had indicated that the Company would be required to meet newly-imposed guidelines before the affected strengths of the Product could receive final approval. The FDA has now rescinded that requirement.
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