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news.Elite Pharmaceuticals, in collaboration with ThePharmaNetwork, a developer and marketer of generic pharmaceuticals, has announced the acceptance by the FDA of the abbreviated new drug application for a generic equivalent of a synthetic narcotic analgesic drug product.
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Elite will manufacture the product and will receive a share of the profits from the sale of the product upon commercialization.
Bernard Berk, chairman and CEO for Elite, said: “We are pleased to reach this milestone and look forward to working with ThePharmaNetwork in this venture. With the revenue generated from the Lodrane products along with the proceeds of our recent capital raise, Elite continues to move forward with the development of our two lead pain products, ELI-216, our abuse resistant oxycodone, and ELI-154, our once daily oxycodone product, and will complete the work necessary for initiating Phase III clinical studies.
“We will continue to seek out additional partnering prospects and other venture opportunities to leverage our proprietary opioid abuse technology and our unique drug delivery systems.”