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Amneal Receives Abbreviated New Drug Application Approval For Lidocaine Patch, 5%

Amneal Pharmaceuticals, Inc. (NYSE:AMRX) ("Amneal" or the "Company") today announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration

Benzinga · 08/25/2020 13:19

Amneal Pharmaceuticals, Inc. (NYSE:AMRX) ("Amneal" or the "Company") today announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for a generic version of Lidocaine Patch, 5%. Lidocaine Patch, 5% is the generic version of Lidoderm Patch, 5% for treatment of post-herpetic neuralgia.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200825005601/en/

"We are pleased to announce the approval for the Lidocaine Patch, 5%, which will be Amneal's first commercialized hydrogel product," said Chirag and Chintu Patel, Co-Chief Executive Officers. "This is our 8th 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, NJ site."

According to IQVIA™, a leading healthcare data and analytics provider, U.S. annual sales for Lidocaine Patch, 5% for the 12 months ended June 2020 were approximately $282 million.