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.
Citizen petitions are filed to ask that the FDA take, or refrain from taking, a particular action. Any person may file a citizen petition, and any person may comment on a petition that has been filed. Petitions are governed by and must comply with FDA regulations, specifically 21 C.F.R. § 10.30, as well as the Federal Food, Drug, and Cosmetic Act, specifically 21 U.S.C. § 355(q) when applicable.
Elite cannot predict when or if the FDA will respond to, or otherwise take any action with respect to, the Citizen Petition.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. develops oral sustained and controlled release products. Elite's strategy includes assisting partner companies in the life cycle management of products to improve off-patent drug products and developing generic versions of controlled release drug products with high barriers to entry. Elite has five commercial products currently being sold, an additional product approved and soon to be launched, and one additional product under review pending approval by the FDA. Elite's lead pipeline products include abuse resistant opioids utilizing the Company's patented proprietary technology, and a once-daily opioid. They are sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse. Elite also provides contract manufacturing for Actavis and Ascend Laboratories (previously a subsidiary of ThePharmaNetwork and now a subsidiary of Alkem Laboratories Ltd.) and has partnered with Mikah Pharma to develop a new product, with Hi-Tech Pharmacal to develop an intermediate for a generic product, and a Hong Kong based company to develop a branded product for the United States market and its territories. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
