Amneal gets US FDA approval for Lidocaine Patch

Amneal Pharmaceuticals has received Abbreviated New Drug Application (ANDA) approval from the US 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 the treatment of post-herpetic neuralgia.

“We are pleased to announce the approval for the Lidocaine Patch, 5%, which will be Amneal’s first commercialised hydrogel product. 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, NJ site,” said Chirag and Chintu Patel, Co-Chief Executive Officers, Amneal Pharmaceuticals.

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