Research & Development
FDA Acknowledges Receipt of Sorrento Therapeutics NDA for ZTlido
12 September 2017 - - US-based biopharmaceutical company Sorrento Therapeutics, Inc.'s (NASDAQ: SRNE) Scilex Pharmaceuticals Inc. majority-owned subsidiary has received from the US Food and Drug Administration acknowledgement of receipt of its recently resubmitted New Drug Application for ZTlido (lidocaine patch 1.8%) which has been considered a complete, class 2 response to the prior action letter, the company said on Tuesday.

The PDUFA (Prescription Drug User Fee Act) goal date for completion of the FDA's review of the Scilex NDA is set for February 28, 2018, which is the standard six-month review period for a class 2 response.

Scilex, a majority-owned subsidiary of Sorrento Therapeutics located in San Diego, California, leverages on its core, proprietary technologies to responsibly develop next generation, branded pharmaceutical products to better manage critical conditions.

The company's lead product under development, ZTlido (lidocaine patch 1.8%), is a branded lidocaine patch formulation for the treatment of relieving the pain of post-herpetic neuralgia, also referred to as after-shingles pain. 

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases.

The company's multimodal multipronged approach to fighting cancer is made possible by its' extensive immuno-oncology platforms, including key assets such as fully human antibodies, clinical stage immuno-cellular therapies, intracellular targeting antibodies, antibody-drug conjugates, and clinical stage oncolytic virus.