TissueGene, Inc. Announces FDA Acceptance Of Invossa™ As Proprietary Name For TissueGene-C
ROCKVILLE, Md., June 24, 2015 /PRNewswire/ -- TissueGene, Inc. today reported that the U.S. Food and Drug Administration (FDA) accepted the proposed brand name Invossa for TissueGene-C, the Company's proprietary product in development for treatment of osteoarthritis of the knee. FDA's acceptance of the proprietary brand name is subject to the Agency's final determination prior to any approval of the product's Biologic License Application (BLA) and market launch. The United States Adopted Names Council (USAN) of the American Medical Association also approved Tonogenchoncel-L as Invossa's generic name for the U.S. market.
The FDA reviews proposed proprietary names, taking into account potential for confusion between the proposed name and the names of marketed drugs and pending products for which marketing applications are currently under review. The brand name also has been submitted for registration to the U.S. Patent and Trademark Office, the European Union, and 19 additional countries.
"We were pleased to see that the branding analyses showed the Invossa name to be attractive at many levels not only in the U.S. but also globally across the US, Europe and Asia," said Woosok Lee, President and Chief Executive Officer of TissueGene. "With FDA's acceptance, we can now accelerate the development of the Invossa brand in the upcoming Phase III clinical trials and the product's market launch."
ABOUT TISSUEGENE, INC.
TissueGene, Rockville, Maryland, specializes in regenerative therapies affecting the joints, nerve and bone. Its novel osteoarthritis drug, TG-C, is designed to conveniently and effectively treat osteoarthritis of the knee by reducing pain, increasing function and slowing the progression of the disease without the side effects usually seen with other palliative options such as NSAIDs or steroids. TissueGene has completed Phase 2 trials of TG-C for an allogeneic cell therapy for osteoarthritis of the knee. Information can be found at the NIH registry,www.clinicaltrials.gov. For additional information about TissueGene, Inc., please visit the Company's website at www.TissueGene.com.
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SOURCE TissueGene, Inc.
Released June 24, 2015