Intellipharmaceutics International Inc.
U.S. FDA Acknowledges Receipt of Intellipharmaceutics' Resubmission of Oxycodone ER New Drug Application, Deems it a Complete Response, and Designates August 28, 2019 as Goal Date for Review
Friday, March 29, 2019 8:00 AM
TORONTO, ON / ACCESSWIRE / March 29, 2019 / Intellipharmaceutics International Inc. (OTCQB: IPCIF and TSX: IPCI) ("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, announced today that the U.S. Food and Drug Administration ("FDA") has acknowledged receipt of its resubmission of the Oxycodone ER New Drug Application ("NDA") filed on February 28, 2019. The FDA has informed the Company that it considers the resubmission a complete response to the September 22, 2017 action letter it issued in respect of the NDA. The FDA has also assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2019.
There can be no assurance that Intellipharmaceutics will not be required to conduct further studies for Oxycodone ER, that the FDA will approve any of the Company's requested abuse-deterrent label claims or that the FDA will meet its deadline for review and ultimately approve the NDA for the sale of Oxycodone ER in the U.S. market, or that it will ever be successfully commercialized.
Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company's patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that can be applied to a wide range of existing and new pharmaceuticals. Intellipharmaceutics has developed several drug delivery systems based on this technology platform, with a pipeline of products (some of which have received FDA approval) in various stages of development. The Company has ANDA and NDA 505(b)(2) drug product candidates in its development pipeline. These include the Company's abuse-deterrent oxycodone hydrochloride extended release formulation ("Oxycodone ER") based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System (for which an NDA has been filed with the FDA), and Regabatin™ XR (pregabalin extended-release capsules).
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Intellipharmaceutics International Inc.
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SOURCE: Intellipharmaceutics International Inc.