Amarex has helped obtain the following market approvals (as of October 2025):

• 2025, 510(k) clearance, Hemoconcentrator (pediatric), Cardiovascular
• 2024, BLA, Allogeneic cell therapy, Hematology & Immunology
• 2024, 510(k) clearance, Hemoconcentrator (adult), Cardiovascular
• 2021, NDA approval, Dhivy^TM, Parkinson’s Disease,
• 2020, EUA, 1copy™ COVID-19 qPCR Multi Kit, infectious disease
• 2020, De Novo granted, EndeavorRx™, ADHD
• 2019, De Novo granted, Plenity, gastroenterology
• 2019, 510(k) clearance, Vstrip^® H. pylori Antigen Rapid Test, infectious disease diagnostic
• 2018, NDA approval, DIACOMIT^®, Seizures
• 2017, 510(k) clearance, SAM, Nephrology
• 2016, PMA approval, dermal regeneration matrix, wound healing device
• 2015, 510(k) clearance, 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, BLA approval, Kineret, pediatric NOMID
• 2012, NDA approval, Pexeva^®, depression and anxiety
• 2012, NDA approval, Moxatag, pain management
• 2012, PMA approval, therascreen KRAS RGQ PCR Kit, oncology diagnostic
• 2011, PMA approval, Solesta^®, gastroenterology
• 2009, NDA approval, FORFIVO XL, major depressive disorder
• 2008, NDA approval, Moxatag, infectious disease
• 2008, NDA approval, Xenazine^®, CNS
• 2002, NDA approval, Abilify MyCite^®, schizophrenia
• 2001, NDA approval, Adderall XR^®, ADHD
• 2001, PMA approval, OrCel^®, wound healing device
• 1999, 510(k) clearance, RLP Cholesterol Immunoseparation Assay, diagnostic
• 1999, NDA approval, Pletal^®, cardiovascular
• 1998, NDA approval, RAXAR™, infectious disease