Elite Pharmaceuticals, Inc. Announces FDA Approves Waiver of NDA Filing Fee and Submit New Drug Application for ELI-200
January 30, 2016 at 01:42 am IST
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Elite Pharmaceuticals, Inc. announced that The United State Food and Drug Administration granted Elite a waiver of the application fee required for the filing of a New Drug Application for Elite's product ELI-200, an immediate release Oxycodone Hydrochloride 5 mg, 10 mg, 15 mg, 20 mg and 30 mg capsules with sequestered Naltrexone Hydrochloride for the treatment of moderate to severe pain. On January 14, 2016, Elite submitted a 505(b)(2) NDA for ELI-200. FDA notification regarding acceptance of the submission for review is expected to take 6 to 12 weeks.
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 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. 
