NESS ZIONA, Israel, Sept. 10, 2020 (GLOBE NEWSWIRE) -- … The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of August 17, 2020. February 08, 2016 08:30 AM Eastern Standard Time. - PDUFA Goal Date Set for April 26, 2021 - Potential to be first FDA-approved single-agent benzoyl peroxide prescription drug product. Version date: October 10, 2017 for all NDAs and BLAs 4 Dimension Evidence and Uncertainties Conclusions and Reasons The goal of treatment is early and aggressive use of medications to try to prevent functional impairment and irreversible joint damage. Current FDA performance goals under the Prescription Drug User Fee Act stipulate that FDA intends to review and act on 90% of standard NDA and BLA submissions within 10 months of the filing date. All other readers will be directed to the abstract and would need to subscribe. Advertisement. Cancel. Table; View full table. Rilonacept is a … The FDA has granted Priority Review and set a Prescription Drug User Fee Act (PDUFA) goal date of July 20, 2021, supporting the Company’s previous guidance of a planned launch in the second half of 2021. Jed Black, MD. Generic Drug Assessment Times Show Improvement In … CAMBRIDGE, Mass.–(BUSINESS WIRE)–Feb. Here are the key PDUFA goal dates for the unfolding month: Merck Seeks Approval For Heart Failure Drug. Pink Sheet. FDA Assigns Prescription Drug User Fee Act (PDUFA) Goal Date of November 16, 2019. The sBLA for rilonacept was accepted for priority review by the FDA in November, with a PDUFA goal date of March 21. Several NMEs have PDUFA goal dates before end of December. Rilonacept is a weekly, subcutaneously-injected … Additionally, the Company recently submitted to the FDA the results of non-clinical analyses the Company previously announced it had agreed to conduct related to toxicology findings in animal studies. Sign In To Set a Search Alert . This publication provides an overview of what to expect from the FDA in 2019 based on established PDUFA dates. Here are the key PDUFA goal dates for the unfolding month: Merck Seeks Approval For Heart Failure Drug. Advertisement. Current Treatment Options The goal for priority review applications is 6 months. Solriamfetol, an investigational agent for the improvement of wakefulness and reduction of excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea (OSA), has had its Prescription Drug User Fee Act (PDUFA) goal date extended an additional 3 months, to March 20, 2019. The FL indication has been accepted for standard review with a PDUFA goal date of June 15, 2021. -- FDA Sets PDUFA Goal Date of October 30, 2020--WATERTOWN, Mass.--(BUSINESS WIRE)--May 26, 2020-- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s … -- PDUFA goal date of July 25, 2021 --DUBLIN, Ireland and CHICAGO, Jan. 25, 2021 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a … The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss this application. Send. Please Note: Only individuals with an active subscription will be able to access the full article. - PDUFA Goal Date Set for August 1, 2021 - Potential to be the first acne treatment that contains a fixed-dose combination of benzoyl peroxide and tretinoin. NESS ZIONA, Israel, Dec. 07, 2020 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for … Related Content. This review target is commonly referred to as the PDUFA goal date. Subject: FDA Performance Tracker: User Fee Goal Dates Add a personalized message to your email. PDUFA goal date extended by standard extension period of three months to May 26, 2016. The Prescription Drug User Fee Act (PDUFA) was created to authorize the Food and Drug Administration (FDA) to collect fees from companies that produce certain human drug and biological products. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 27, 2021. The FDA also stated it continues to anticipate meeting the Prescription Drug User Fee Act (PDUFA) goal date for the application review, which is December 18, 2020. Pink Sheet. “There remains a critical need for additional therapies in large B-cell lymphoma, particularly for relapsed or refractory patients,” said Stanley Frankel, M.D., senior vice president, Cellular Therapy Development, Bristol-Myers Squibb. However, FDA is currently experimenting with alternative review timelines (e.g., Can Athenex' Oral Chemotherapy Medication Pass FDA Muster? As a result, the potential exists for the highest number of approvals since the mid‐90’s. MALVERN, Pa., Jan. 22, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a specialty pharmaceutical company focused on therapeutics for acute care settings, today announced that the U.S. Food and Drug Administration (FDA) has set a PDUFA goal date of February 20, 2020 for its decision on the New Drug Application (NDA) for intravenous (IV) meloxicam for the management of … – FDA grants Priority Review of application and sets PDUFA goal date of November 27, 2020 –. -FDA sets PDUFA goal date of July 2, 2021--If approved, teplizumab will be the first disease-modifying therapy for type 1 diabetes-News provided by. Source: File Photo Sponsors are interested to learn more about when the US FDA will miss a goal date in order to reach a faster ANDA approval or tentative approval. ANDA User Fee Misses Are Mostly Part Of 'Imminent Approval' Process 26 Nov 2019. Following FDA acceptance of the regulatory application for priority review, the PDUFA goal date was fixed at Feb. 28. "Since submitting the BLA for margetuximab, we have worked collaboratively with the FDA to answer the Agency’s questions as they arise," said Scott Koenig, M.D., President and CEO of MacroGenics. PDUFA goal date extended by standard extension period of three months to May 26, 2016. The application was accepted by the FDA for priority review In August, with a PDUFA goal date of Feb. 15. The sBLA for rilonacept was accepted for priority review by the FDA in November, with a PDUFA goal date of March 21. The lumateperone Prescription Drug User Fee Act (PDUFA) goal date is December 27, 2019. Date: March 21. NME approvals in 2012 include a number of “breakthrough” drugs that provide much needed new treatment options for patients.