Amarex has helped obtain the following market appr
Post# of 155121
(Total Views: 840)
Posted On: 12/15/2021 8:27:46 PM
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
Amarex Approvals
Never filed a successful BLA. It makes me wonder if our RTF was their first ever attempt and the shortcomings were more indicative of incompetence than malfeasance. Either way, we should accept some blame for using a CRO that didn't have a track record of successful BLA's.
Which makes me wonder about Symbio Research as one our two new CRO's. Specialists in dermatology clincal trials, they boast of over 55 FDA approvals including over 50+ approvals as a result of their dermatology trials. I struggle to see how this is a good fit with leronlimab.
PPD on the other hand seems rock solid, IMO
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
Amarex Approvals
Never filed a successful BLA. It makes me wonder if our RTF was their first ever attempt and the shortcomings were more indicative of incompetence than malfeasance. Either way, we should accept some blame for using a CRO that didn't have a track record of successful BLA's.
Which makes me wonder about Symbio Research as one our two new CRO's. Specialists in dermatology clincal trials, they boast of over 55 FDA approvals including over 50+ approvals as a result of their dermatology trials. I struggle to see how this is a good fit with leronlimab.
PPD on the other hand seems rock solid, IMO
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