Noven ADHD patches in short supply after recall

Noven has been recalling tens of thousands of boxes of its Daytrana patches from the market because of issues over peeling away a protective liner to deliver the ADHD drug. More recently, the drugmaker has warned customers that the patches are out of stock and won’t be readily available until August.

Noven began recalling more than 125,000 of the methylphenidate transdermal patches in July 2015, but according to the most recent FDA Enforcement report, Noven began retrieving another 22,223 boxes of the patches in different strengths, a recall the FDA only this week classified and posted on its website. According to reports, Noven began the recalls last year after an FDA inspection resulted in a Form 483 with 13 observations.

The patches were recalled because they were out of spec for their mechanical peel force and z-statistic value. The drugmaker explained that relates to the patient’s or caregiver’s ability to remove the release liner from the patch adhesive prior to administration. The patches, which were manufactured at Noven’s facility in Miami, FL, are approved for children and adolescents.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

Then in April, Noven announced that there was “a shortage of all strengths of Daytrana that is expected to last until third quarter of this year.”

Noven, a stand-alone operating subsidiary of Japan-based Hisamitsu Pharmaceutical, did not respond to a request for comment. The company has twice received FDA warning letters, one in 2008 and one in 2011, a couple of years after Hisamitsu bought the company for $430 million.

Noven is not the only drugmaker in the midst of a recall of an ADHD drug. Allergan ($AGN) has been recalling more than 50 lots, consisting of nearly 600,000 bottles, of its copy of the ADHD drug Adderall.

- find the recalls here
- the Noven shortage notice can be found here

Related Articles: 
Japan's Hisamitsu bags Noven for $430M
Allergan’s Actavis recalls nearly 600,000 bottles of ADHD drug


Suggested Articles

Boehringer Ingelheim has invested €225 million on inhaler production with a new plant in Spain and expanded lines in Germany.

Generic pain drug maker Lannett is closing its plant in Wyoming and laying off the remaining 80 employees.

Turkey is getting its first locally produced mAb via an Iranian biosimilars marker and the $100 million plant it built there.