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Kush Dhody discussing market approvals with staff - Market Approvals | Amarex

Market Approvals

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
  • Executive team in clinical product development meeting - Therapeutic Areas | Amarex

    Therapeutic Areas

    We have more than two decades of experience successfully performing clinical trials in all major therapeutic areas.

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