Amarex has helped obtain the following market approvals:

• 2020, 510(k) approval, 1copy™ COVID-19 qPCR Multi Kit, infectious disease
• 2020, De Novo approval, EndeavorRx™, 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 and 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 MyCite^®, 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