Emmaus Life Sciences Announces Outcome of FDA Inspection of Postmarketing Adverse Drug Experience Compliance Program
The PADE program aims to shield patients from poor quality, unsafe, and ineffective dugs through proactive compliance strategies and risk-based enforcement actions. A major objective of the PADE program is to ensure that accurate, reliable, and timely safety data are submitted to the FDA in compliance with postmarking laws and regulations.
The two and a half-day inspection by two FDA Consumer Safety Officers found no objectional condition or practice in the six years that Endari has been marketed and thereby received a "No Action Indicated" (NAI) inspection classification. "Based on the 2019 FDA inspection results survey, this places Emmaus within the top 16% of all companies investigated in 2019," stated
More about the PADE program
Additional information on the PADE compliance program (inspection classifications, and inspection observations made during the Fiscal Year 2017 through 2019 from the Postmarketing Drug Safety Compliance Inspections --
About Emmaus Life Sciences
About Endari® (prescription grade L-glutamine oral powder)
Endari®, Emmaus' prescription grade L-glutamine oral powder, was approved by the FDA in
Indication
Endari® is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.
Important Safety Information
The most common adverse reactions (incidence >10 percent) in clinical studies were constipation, nausea, headache, abdominal pain, cough, pain in extremities, back pain, and chest pain.
Adverse reactions leading to treatment discontinuation included one case each of hypersplenism, abdominal pain, dyspepsia, burning sensation, and hot flash.
The safety and efficacy of Endari® in pediatric patients with sickle cell disease younger than five years of age has not been established.
For more information, please see full Prescribing Information of Endari at: www.ENDARIrx.com/PI.
About Sickle Cell Disease
There are approximately 100,000 people living with sickle cell disease (SCD) in
1Source: Data & Statistics on Sickle Cell Disease – National Center on Birth Defects and Developmental Disabilities,
2Source:
Throughout the Middle East North Africa region, Emmaus estimates that there are approximately 225,000 sickle cell disease patients that could potentially be treated with Endari®.
Company Contact:
Willis Lee
Chief Operating Officer
(310) 214-0065, Ext. 1130
wlee@emmauslifesciences.com
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