Amarex has helped obtain the following market approvals:

2020, 510(k) Approval, 1copy COVID-19 qPCR Multi Kit, Infectious Disease
2020, De Novo Approval, Endeavor RX, ADHD
2019, De Novo Approval, Weight Management Aid, Gastroenterology
2019, 510(k) Approval, Vstrip H. pylori Antigen Rapid Test, Infectious Disease Diagnostic
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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