Elite Pharmaceuticals Inc (ELTP)

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Elite Laboratories Files Citizen Petition With the FDA on Brompheniramine Maleate and Pseudoephedrine HCL Extended Release


Elite Laboratories, a wholly owned subsidiary of Elite Pharmaceuticals, Inc. (collectively ""Elite" or the "Company") (OTCBB:ELTP) today announced that the Company submitted a Citizen Petition to the U.S. Food and Drug Administration (the "FDA") requesting that the FDA make a determination that (a) it is suitable to use the currently approved and marketed ANDA product (ANDA 078648, generic to Drixoral brand) as the Reference Listed Drug ("RLD") since the current RLD Drixoral brand is no longer available in the marketplace, and (b) that this currently approved and marketed ANDA product is suitable to use as a RLD for an equivalent active ingredient comprised of a difference salt.
The filing of the Citizen Petition represents another step forward in Elite's continuing efforts to reintroduce its extended release brompheniramine maleate and pseudoephedrine hydrochloride to the marketplace.