ZTlido
Generic name: lidocaine
Treatment for: Postherpetic Neuralgia
FDA Accepts Scilex Pharmaceuticals' NDA Filing for ZTlido
MALVERN, Pa., Sept. 16, 2015 /PRNewswire/ -- Scilex Pharmaceuticals, Inc., a company engaged in the development and commercialization of products focused on the treatment of pain, today announced that the FDA has accepted for filing its new drug application for ZTlido (lidocaine patch 1.8%).
This marks a significant step on the path to commercialization for ZTlido, following the recent filing of Scilex's NDA for the product as part of its 505(b)(2) regulatory pathway during the third quarter of 2015.
ZTlido is Scilex's flagship product, a branded fourth-generation patch being developed for the treatment of postherpetic neuralgia, or after-shingles pain.
In addition to the progress with ZTlido™, Scilex is expanding its product suite for the treatment of pain with the development of several other products.
About Scilex Pharmaceuticals
Scilex Pharmaceuticals, Inc., located in Malvern, PA, responsibly develops and brings branded pharmaceutical products to market using groundbreaking technologies that maximize quality of life for all. We are uncompromising in our focus to become the global pharmaceutical leader committed to social, environmental, economic, and ethical responsibility. Dedicated to using our internal partnerships, we deliver the next generation of trailblazing products that are responsible by design. The Company's first product under development, ZTlido™ (lidocaine patch 1.8%), is a next-generation branded lidocaine patch formulation for the potential treatment of relieving the pain of postherpetic neuralgia, also referred to as after-shingles pain. For more information visit www.scilexpharma.com.
ZTlido™ is a trademark owned by Scilex Pharmaceuticals, Inc. A proprietary name review by the FDA is planned.
Source: Scilex Pharmaceuticals, Inc.
Posted: September 2015
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- Sorrento Therapeutics Subsidiary, Scilex, Receives FDA Approval for Non-Opioid ZTlido (lidocaine topical system) 1.8% for Post-Herpetic Neuralgia Pain - February 28, 2018
- FDA Acknowledges Receipt of Sorrento Therapeutics Inc, NDA for ZTlido - September 12, 2017
- Sorrento Therapeutics, Inc. Submits NDA For ZTlido Next-Generation Lidocaine Patch - August 29, 2017
- Scilex Pharmaceuticals Initiates Pivotal Pharmacokinetic Study for Ztilido - May 15, 2014
- Scilex Pharmaceuticals Announces Filing of Investigational New Drug Application for Ztilido - March 24, 2014
ZTlido (lidocaine) FDA Approval History
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