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Wednesday, December 02, 2009 5:22:29 PM

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ELTP FDA approval PR:


Elite Pharmaceutics and ThePharmaNetwork Announce FDA Approval for Generic Methadone Tablets
Wednesday 12/02/2009 10:50 AM ET - Globenewswire

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Symbol Last %Chg
ELTP 0.135 39.90%
As of 3:59 PM ET 12/2/09

Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) and ThePharmaNetwork, LLC ("TPN") announced today the approval of an Abbreviated New Drug Application (ANDA) for methadone hydrochloride 10 mg tablets by the U.S. Food and Drug Administration (FDA). Elite and TPN co-developed the product and the product was filed under ThePharmaNetwork name. The methadone hydrochloride tablets are the generic equivalent of the Dolophine(R) hydrochloride 10 mg tablets. The product and its equivalents had annual sales of approximately $48 million in 2008. Under the Product Collaboration Agreement, Elite will manufacture the product and Elite and TPN will share in the profits from the sale of the product.

About TPN

ThePharmaNetwork, LLC is engaged in the development, manufacturing, licensing, and marketing of strategically selected generic pharmaceuticals as well as providing comprehensive business development solutions that utilize its well established network of international business relationships. ThePharmaNetwork, LLC sells generic pharmaceuticals under its Ascend Laboratories label to all major classes of trade.

About Elite Pharmaceuticals

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. Two of Elite's products, Lodrane 24(R) and Lodrane 24D(R), are marketed by a partner, ECR Pharmaceuticals, for allergy treatment. Elite's lead pipeline products are novel sustained release oral formulations of oxycodone 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. Both products, ELI-216, a once-daily abuse resistant oxycodone, and ELI-154, a once-daily oxycodone, are in late-stage development. Elite, with partners, also has an ANDA filed with the FDA for a generic equivalent of a pain product and has a generic gastrointestinal drug product in clinical development. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.

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