United State Food and Drug Administration Approves Waiver of New Drug Application Filing Fee for Elite Pharmaceuticals, Inc
January 13, 2016 at 09:52 pm
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The United State Food and Drug Administration granted Elite Pharmaceuticals, Inc. a waiver of the application fee required for the filing of a New Drug Application (NDA). Under section 736(d)(1)(E) of the Federal Food, Drug and Cosmetic Act the FDA may grant a waiver of the $2,335,200 NDA application fee for the first human drug application that a small business submits for review. Elite will immediately submit a 505(b)(2) New Drug Application for its lead opioid abuse-deterrent candidate ELI-200, immediate-release Oxycodone Hydrochloride 5mg, 10mg, 15 mg, 20 mg and 30mg capsules with sequestered Naltrexone Hydrochloride, for the treatment of moderate to severe pain with the United States Food and Drug Administration.
FDA notification regarding acceptance of the submission for review is expected to take 6 to 12 weeks.
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, Phendimetrazine Tartrate 35mg tablets, Phentermine HCl 15mg and 30mg capsules, Naltrexone HCl 50mg tablets, Trimipramine Maleate Immediate Release 25mg, 50mg and 100mg capsules, 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.
ELITE PHARMACEUTICALS, INC. 
