MARKET APPROVALS
510(k) Approval
Vstrip
Gastroenterology
2019
NDA Approval
Diacomit
Seizures
2018
510(k) Approval
SAM
Nephrology
2017
PMA Approval
Dermal Regneration Matrix
Wound Healing Device
2016
PMA Approval
Insti HIV-1/HIV-2 Antibody Test
Diagnostic
2010/2015
510(k) Approval
Bond Ease Topical Skin Adhesive
Wound Healing Device
2015
NDA Approval
Brisdelle
Vasomotor Symptoms
2013
BLA Approval
Kineret
Pediatric NOMID
2013
PMA Approval
Therascreen KRAS RGQ PCR Kit
Oncology Diagnostic
2012
NDA Approval
Subsys
Pain Management
2012
PMA Approval
Solesta
Gastroenterology
2011
NDA Approval
Amoxicillin Pulsys
Infectious Disease
2008
NDA Approval
Xenazine
CNS
2008
NDA Approval
Abilify
Schizophrenia
2002
NDA Approval
Adderall XR
ADHD
2001
PMA Approval
RLP-C Assay
Diagnostic
2001
PMA Approval
OrCel
Wound Healing Device
2001
NDA Approval
Pletal
Cardiovascular
1999
NDA Approval
Raxar
Infectious Disease
1998