FDA clears Amneal’s lidocaine patch 5%

Amneal has received Food and Drug Administration approval for its lidocaine patch 5%. The product is a generic of Lidoderm Patch 5%. 

“We are pleased to announce the approval for the Lidocaine Patch, 5%, which will be Amneal’s first commercialized hydrogel product,” Amneal co-CEOs Chirag and Chintu Patel said in a statement. “This is our eighth of the 15 complex products we expect to launch by August 2021, further reinforcing our confidence in our extensive pipeline and global manufacturing capabilities. Amneal has expertise in both Matrix-based as well as Hydrogel-based patches, which are manufactured at our Piscataway, N.J., site.”

The product had annual sales of roughly $282 million for the year ended June 2020, according to IQVIA data.