List below, ANDA approvals are coming!
Aug. 10, 2016 - Elite Pharmaceuticals files ANDA to Market Generic Percocet
Elite Pharmaceuticals, Inc. 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.
Dec. 12, 2016 - Elite Pharmaceuticals Files ANDA for Hydrocodone and Acetaminophen Combo
Elite Pharmaceuticals, Inc. 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.
April 04, 2017 - Elite Pharmaceuticals Files ANDA for Pain Product
Elite Pharmaceuticals, Inc. today announced that it had filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of a synthetic narcotic analgesic indicated for the management of pain. The branded product and its equivalents had annual sales of over $40 million in 2016 according to IMS Health data.
Sept. 20, 2017 - Elite Pharmaceuticals Files ANDA for Oxycodone Hydrochloride Extended Release
Elite Pharmaceuticals, Inc. announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of OxyContin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. OxyContin® is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016.
Feb. 08, 2018 - Elite Pharmaceuticals and SunGen Pharma File ANDA
Elite Pharmaceuticals, Inc. a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, 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 an immediate release CNS stimulant. The ANDA represents the first filing for a product co-developed with SunGen Pharma, LLC ("SunGen") under the Development and License Agreement ("Agreement"). According to IMS Health data the branded product and its equivalents had total U.S. sales of more than $400 million for the twelve months ending September 30, 2017.
May 30, 2018 - Elite Pharmaceuticals and SunGen Pharma File ANDA for Extended-Release CNS Stimulant
Elite Pharmaceuticals, Inc. a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, 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 an extended-release CNS stimulant. The ANDA represents the filing of a second product co-developed with SunGen Pharma, LLC ("SunGen"). In February Elite and SunGen filed an ANDA to a generic version of an immediate-release CNS stimulant. According to QuintilesIMS Health data the branded product for the extended-release CNS stimulant and its equivalents had total U.S. sales of approximately $1.6 billion for the twelve months ending September 30, 2017.
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