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US FDA grants Kitova a waiver for new drug application filing fee
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Tel Aviv, Israel
Tuesday, April 04, 2017, 10:00 Hrs  [IST]

Kitov Pharmaceuticals Holdings Ltd., an innovative biopharmaceutical company, has announced that the US Food and Drug Administration (FDA) has granted Kitov a waiver related to the $2,038,100 New Drug Application (NDA 210045) filing fee for KIT-302. KIT-302 is Kitov’s patented combination of Amlodipine Besylate-Celecoxib tablets, intended to treat osteoarthritis pain and hypertension simultaneously.

J. Paul Waymack, M.D., Sc.D., Kitov’s chairman of the board and chief medical officer, commented, “We are pleased to receive this NDA fee waiver for KIT-302 and look forward to continuing to work with the FDA through the NDA submission and review process. We are focused on finalizing our NDA submission to the FDA, which we expect will occur during the current calendar quarter.”

The fee waiver, which Kitov requested in accordance with sections 736(d)(1)(D) of the Federal Food, Drug and Cosmetic Act, is granted to a small business for its first human drug application submitted to the FDA for review. The Company will not be required to remit the NDA filing fee, provided that the marketing application for KIT-302 is filed prior to March 27, 2018.

Kitov Pharmaceuticals is an innovative biopharmaceutical drug development company. Leveraging deep regulatory and clinical-trial expertise, Kitov’s veteran team of healthcare professionals maintains a proven track record in streamlined end-to-end drug development and approval. Kitov’s flagship combination drug, KIT-302, intended to treat osteoarthritis pain and hypertension simultaneously, achieved the primary efficacy endpoint for its Phase III clinical trial and its New Drug Application for the US Food and Drug Administration is currently being prepared for submission.

Kitov’s newest drug, NT219, which is developed by its majority owned subsidiary, TyrNovo Ltd., is a small molecule that presents a new concept in cancer therapy, and in combination with various approved oncology drugs, demonstrated potent anti-tumor effects and increased survival in various cancer models. By lowering development risk and cost through fast-track regulatory approval of novel late-stage therapeutics, Kitov plans to deliver rapid ROI and long-term potential to investors, while making a meaningful impact on people’s lives.

 Courtesy – Pharmabiz


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