US FDA halts India's Sun Pharma trials on dermatological drug
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[May 02, 2023]
BENGALURU (Reuters) -The U.S. Food and Drug Administration (FDA)
has asked India's Sun Pharmaceutical Industries Ltd to halt tests on one
dose of an experimental dermatological drug due to the potential of
blood clots, the company said on Tuesday.
The FDA has also said that patients with alopecia areata - an autoimmune
condition that results in patchy hair loss - on the 12 mg dose of the
drug deuruxolitinib should discontinue its use, Sun Pharma said.
However, there were no thrombotic events, or blood clot formations, in
patients taking the 8 mg dose and the FDA has not placed those trials on
hold, Sun Pharma said.
The company said it would work closely with the FDA to address the
agency's concerns, which the drugmaker expected to be communicated
within the next 30 days.
Sun Pharma, India's largest drugmaker by revenue, acquired
deuruxolitinib when it bought U.S.-based Concert Pharmaceuticals for
$576 million earlier this year.
This is Sun Pharma's second run-in with the FDA in less than two weeks.
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![](../images/050223PIX/health83.jpg)
A bird flies past the logo of Sun Pharma
installed on the facade of its corporate office in Mumbai, India,
November 14, 2017. REUTERS/Shailesh Andrade/File Photo/File Photo
![](http://archives.lincolndailynews.com/2015/May/02/images/ads/current/guzzardo_lda022609.png) In late April, the company said it
would need to, at the behest of the FDA, take "certain corrective
actions" at its facility in Mohali before it could export from there
to the United States.
Sun Pharma's shares were down 0.3% in morning trading, while the
Nifty Pharma index was up 0.35%.
(Reporting by Rama Venkat in Bengaluru; Editing by Rashmi Aich and
Varun H K)
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