Elite Reports on SequestOx FDA End-of-Review Meeting
January 23, 2017 at 01:19 pm
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Elite Pharmaceuticals, Inc. reported the company received official minutes from its December 21, 2016 end-of-review meeting with the U.S. Food and Drug Administration (the “FDA”) for the New Drug Application (the “NDA”) for SequestOx (oxycodone hydrochloride and sequestered naltrexone hydrochloride). The meeting minutes support a plan to address the issues cited by the FDA in the July 14th Complete Response Letter by modifying the SequestOx formulation. Elite will proceed immediately to complete in vitro and in vivo bridging studies required and expects to resubmit the SequestOx application later this year. The in vivo studies include bioequivalence and bioavailability fed and fasted studies comparing the modified formulation to the original formulation. SequestOx is Elite’s investigational abuse-deterrent opioid candidate for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops and distributes niche generic products. The Company specializes in developing and manufacturing oral, controlled-release drug products. It owns multiple generic products which has been licensed to Prasco, LLC and TAGI Pharma. The Companyâs segments include Abbreviated New Drug Applications (ANDA) and New Drug Application (NDA). The Companyâs products include Phentermine HCl 37.5mg tablets, Loxapine Succinate 5mg, 10mg, 25mg and 50gm capsules, Phentermine HCl 15mg and 30mg capsules, Naltrexone HCl 50mg tablets, Dantrolene Sodium Capsules 25mg, 50mg and 100mg, Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Immediate Release 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg tablets, Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended Release 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg capsules and others.