4 ANDA approvals could be announced at any time soon. FDA goal is 10 months. Elite has 4 already within that timeframe! FDA laughable questions have create delays with some but that time delay is short or past due so approvals can hit at any time!
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.
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