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

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