Replies to post #243625 on Elite Pharmaceuticals Inc (ELTP)

[Couch]

THis comapny is all based on HOPES and DREAMS.

Sure okay - the FACTS say otherwise. REMIND ME AGAIN how many months for Generic approval.....WHOOPSY it isn't 48 months.

*******Woodcock made clear that the median times cited by Alexander include ANDAs that have technically been backlogged since GDUFA began, though this year, it will take FDA about 15 months to respond to a generic firm on their ANDA. And in October 2016, companies can expect to get a response within 10 months from FDA. Woodcock also noted a case when a generic was approved at nine months, and just last month FDA approved 99 ANDAs. - See more at: http://www.raps.org/Regulatory-Focus/News/2016/01/28/24195/FDA%E2%80%99s-Woodcock-Generic-Drug-Application-Backlog-Will-be-Eliminated-Before-GDUFA-II/#sthash.1VvRxBrR.dpuf

1) Elite Pharmaceuticals Reports Positive Topline Results From A Pivotal Bioequivalence Study For A Generic OxyContin®
NORTHVALE, N.J, Jan. 17, 2017 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) today reported positive topline results from a pivotal bioequivalence fed study initiated in November 2016. The topline results indicate that Elite's generic product is bioequivalent to the branded product, OxyContin® (extended release Oxycodone Hydrochloride). A fasted study was previously conducted in September 2016, also with positive results.

The study was a single dose crossover comparative bioavailability study of Oxycodone HCl extended release in healthy volunteers under fed conditions. The Elite product is a generic formulation of the branded product, OxyContin®, with strengths of 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg, and incorporates physical abuse deterrent properties. IMS reported approximately $2.5 billion in revenue for OxyContin in 2015.

2) Elite Pharmaceuticals Files ANDA For Hydrocodone And Acetaminophen Combo
NORTHVALE, N.J., Dec. 12, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets, USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have total annual US sales of approximately $700 million according to IMS Health data.

"Hydrocodone/acetaminophen is a strategic addition to Elite's pain medicine portfolio. This immediate release opioid product is used extensively by doctors today in pain management. The acetaminophen creates irritation if the product is crushed and taken intranasally, thereby potentially providing some intranasal abuse-deterrence according to the FDA," said Nasrat Hakim, President and CEO of Elite. "Elite is committed to developing a diverse range of opioid abuse-deterrent pain products using our proprietary technology and building a foundation of attractive niche generic drugs."

3) Elite Announces Development And License Agreement With SunGen Pharma LLC
Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB:ELTP), a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, today announced it has entered into a Development and License Agreement (“Agreement”) with SunGen Pharma, LLC (“SunGen”) to collaborate to develop and commercialize four generic pharmaceutical products.

Under the terms of the agreement, Elite and SunGen will share in the responsibilities and costs in the development of the products. Upon approval, the products will be owned jointly by Elite and SunGen. SunGen shall have the exclusive right to market and sell two of the products using SunGen’s label and Elite shall have the exclusive right to market and sell two of the products using Elite’s label. Elite will manufacture and package all four products on a cost plus basis.

Two of the products are classified as CNS stimulants and two of the products are classified as beta blockers. For the twelve months ending June 30, 2016, the four products and their generic equivalents had total U.S. sales of more than $3 billion according to IMS Health Data.

4) Elite Pharmaceuticals Files ANDA To Market Generic Percocet
NORTHVALE, N.J., Aug. 10, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Percocet (oxycodone hydrochloride and acetaminophen, USP CII) 5 mg, 7.5 mg and 10 mg tablets with 325 mg of acetaminophen. Percocet is a combination medication and is used to help relieve moderate to severe pain.

Percocet and its generic equivalents had total US sales of approximately $700 million in 2015, according to IMS Health data.

"Oxycodone APAP is a strategic addition to Elite's portfolio. It is an immediate release opioid product used extensively by doctors today in pain management. The APAP creates irritation if the product is crushed and taken intranasally, and so may provide some intranasal abuse-deterrence according to the FDA," said Nasrat Hakim, President and CEO of Elite. "Elite is committed to developing a diverse range of opioid abuse-deterrent products both using our proprietary technology and building a foundation of attractive niche generic drugs. Elite also expects to file another generic opioid product this year."