( IPCI IPCI.T ) Intellipharmaceutics Announces FDA Final Approval of Generic Effexor® XR
5:05 PM ET 11/27/18 | Dow Jones
TORONTO, ON / ACCESSWIRE / November 27, 2018 / Intellipharmaceutics International Inc. (NASDAQ 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, today announced that it has received final approval from the U.S. Food and Drug Administration ("FDA") for the Company's abbreviated new drug application ("ANDA") for venlafaxine hydrochloride extended-release capsules in the 37.5, 75, and 150 mg strengths. The approved product is a generic equivalent of the branded product Effexor(R) XR sold in the U.S. by Wyeth Pharmaceuticals, LLC.
Dr. Isa Odidi, CEO of Intellipharmaceutics, stated, "We believe that the approval of our application for a generic version of Effexor(R) XR is a validation of the scope of our drug delivery technologies and formulation capabilities, and that it also demonstrates our regulatory capabilities and commitment to obtaining regulatory approvals for our pipeline of product candidates still awaiting FDA approval. We are actively exploring the best approach to maximize our commercial returns from this new approval."
Effexor(R) XR, and the drug active venlafaxine hydrochloride, are indicated for the treatment of major depressive disorder ("MDD").
According to Symphony Health Solutions Corporation, sales in the United States for the 12 months ended October, 2018 of the 37.5, 75 and 150 mg strengths of Effexor(R) XR and all generic equivalents, were approximately $470 million (in TRx MBS Dollars, which represents projected new and refilled prescriptions representing a standardized dollar metric based on manufacturer's published catalog or list prices to wholesalers and does not represent actual transaction prices and does not include prompt pay or other discounts, rebates or reductions in price).
The Company is aware that other generic versions of this product are currently available in the market. There can be no assurance that the Company's venlafaxine hydrochloride extended-release capsules for the 37.5 mg, 75 mg, and 150 mg will be successfully commercialized and produce significant revenue for us.
About Intellipharmaceutics
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(TM) 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 new drug application ("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(TM) novel Point Of Divergence Drug Delivery System (for which an NDA has been filed with the FDA), and Regabatin(TM) XR (pregabalin extended-release capsules).
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