Company for the delivery of medicines IntelGenx Corp. IGXT‘s development candidate Buprenorphine buccal filmfor what Abbreviated Authorization of New Drugs (ANDA) was submitted by Chemo research SL through its generic pharmaceuticals agent and affiliates Xiromed LLC (the US division of Insud Pharma SL) received a FDA Generic Drug Fees Act (GDUFA) dated April 28, 2023.
Corresponding FDA’s sidethe Generic Fees Ordinance 2012 (GDUFA). designed to speed public access to safe and effective generic medicines and reduce costs to industrywith the ultimate Goal to ensure patients Access to “safe, high quality and affordable generic medicines”.
This law obliges the industry to do so pay usage fees the cost of reviewing generic drug applications and inspecting facilities in a in time. As submitted by IntelGenx, ANDA received a Final Review Date for 2023 when the result is positivethe company would be allowed to start soon thereafter commercialize its generic.
dr Horst G. Zerbe, CEO of IntelGenx said the company is pleased that its long-standing partnership with Xiromed led to the submission to the FDA suggesting that the review will be completed early in the second quarter of next year.
“Our generic version of Belbuca is designed to a bioequivalent, less expensive alternative for patients. We look forward to the FDA’s decision and, if positive, commercialization of buprenorphine buccal film as soon as possible,” said the CEO.
Belbuca, first approved by the FDA in 2015is applied to the oral or oral mucosa every 12 hours and is available in seven strengths from 0.075 mg to 0.9 mg.
Like its predecessor, the generic buprenorphine buccal film is designed as a Opioid used to treat severe pain that requires long-term daily treatment where other pain treatments are not enough. Its development, which started in September 2016, includes that of IntelGenx versafilm technology in a newly developed formulation…
