MARKET APPROVALS

Market Approvals

Amarex has helped obtain the following market approvals:

  • 2018, NDA Approval, Diacomit, Anticonvulsant

  • 2017, 510(k) Approval, Gastroenterology/Urology 

  • 2016, PMA Approval, Dermal Regeneration Matrix, Wound Healing Device

  • 2015, 510(k) Approval, BondEase Topical Skin Adhesive, Wound Healing Device

  • 2010/2015, PMA Approval, INSTI HIV-1/HIV-2 Antibody Test Kit, Diagnostic

  • 2013, NDA Approval, Brisdelle, Vasomotor Symptoms 

  • 2013, NDA Approval, Pediatric Inflammatory Disease

  • 2012, NDA Approval, Pexeva, Depression & Anxiety

  • 2012, NDA Approval, Pain Management

  • 2012, PMA Approval, therascreen KRAS RGQ PCR Kit, Oncology Diagnostic

  • 2011, PMA Approval, Solesta, Gastroenterology

  • 2009, NDA Approval, QuitPak, Addiction

  • 2008, NDA Approval, Amoxicillin PULSYS, Infectious Disease

  • 2008, NDA Approval, Xenazine, Central Nervous System

  • 2002, NDA Approval, Abilify, Schizophrenia

  • 2001, NDA Approval, Adderall XR, ADHD

  • 2001, PMA Approval, OrCel, Wound Healing Device

  • 2001, PMA Approval, Remnant-Like Particles-Cholesterol (RLP-C) Assay, Diagnostic

  • 1999, NDA Approval, Pletal, Cardiovascular 

  • 1998, NDA Approval, RAXAR, Infectious Disease 

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