Elite Pharmaceuticals Reports Positive Results from A Pivotal Bioequivalence Study
February 07, 2023 at 07:00 am EST
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Elite Pharmaceuticals, Inc. reported positive results from pivotal fasted bioequivalence studies for an undisclosed generic drug product in a class of medications called antimetabolites . IQVIA reported annual sales for the twelve months ending December 2022 of $42 million for the generic market for this product. The studies were open label, single-dose crossover comparative bioavailability studies in volunteers of male and female patients who were already on established drug regimens under fasting conditions.
The results indicate that the generic product is bioequivalent to the branded product. Elite is compiling the data for this product to file an Abbreviated New Drug Application with the US Food and Drug Administration.
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. 
