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 … The FDA has designated this application as a priority review and consequently assigned a PDUFA (Prescription Drug User Fee Act) goal date for completion of the review of oral sulopenem of July 25, 2021. If FDA anticipates missing a PDUFA or BsUFA goal date because of the current public health emergency, we will communicate with the sponsor or applicant directly. Historically, the FDA has been able to exceed this PDUFA performance goal. JZP-258 represents between 1,000 and 1,500 milligrams daily reduction of sodium for … Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a goal date of November 24, 2020. "We are pleased that the FDA considers our POSIMIR submission to be complete," DURECT President and CEO James E. Brown said in the release. To date in CY12, CDER has approved 31 NME applications – CY 12 total to date is one more than the total approved in CY11 and highest total since 2004. The FDA set a PDUFA goal date of Dec. 27, 2019. A Prescription Drug User Fee Act (PDUFA) goal date has been set for August 7, 2020. Notably, in the letter, FDA acknowledged our stated objective of lowering the cost of this drug. FDA Assigns Prescription Drug User Fee Act (PDUFA) Goal Date of November 16, 2019. Streamline your research and quickly compare the relative timing of competing catalysts. Rilonacept is a weekly, subcutaneously-injected … - PDUFA Goal Date Set for April 26, 2021 - Potential to be first FDA-approved single-agent benzoyl peroxide prescription drug product. Rilonacept is a weekly, subcutaneously-injected, recombinant dimeric fusion protein that blocks interleukin-1 … The lumateperone Prescription Drug User Fee Act (PDUFA) goal date is December 27, 2019. SOLANA BEACH, Calif., Jan. 21, 2020 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on the development of drugs to treat gastrointestinal (GI) disorders and diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s resubmission of its 505(b)(2) New … The application was accepted by the FDA for priority review In August, with a PDUFA goal date of Feb. 15. Arthur Przybyl, ANI’s President and CEO commented, “The acceptance of our filing with a confirmed four-month goal date is an important milestone in our re-commercialization effort for this drug. The agency currently plans to hold an advisory committee meeting to discuss the NDA. In their acknowledgement letter, FDA stated that the Company’s resubmission is a complete, Class 2 response to the Agency’s action letter dated November 2, 2018. The FDA stated that the PDUFA goal date has been extended by three months to allow for a full review of the submission. The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for Twyneo is August 1, 2021. -FDA sets PDUFA goal date of July 2, 2021--If approved, teplizumab will be the first disease-modifying therapy for type 1 diabetes-January 04, 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. “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, … The Company expects that it will continue to have exchanges with the FDA as the September 27, 2020 Prescription Drug User Fee Act (PDUFA) goal date approaches. 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. Jed Black, MD. (postmarketing safety) Review Completion Date July 10, 2008 Established Name Caspofungin acetate – FDA grants Priority Review of application and sets PDUFA goal date of November 27, 2020 –. The PDUFA (Prescription Drug User Fee Act) goal date for the completion of the bempedoic acid NDA review is set for February 21, 2020, and the PDUFA goal date for completion of the bempedoic acid / ezetimibe combination tablet NDA review is set for February 26, 2020. Letter Date January 31, 2008 Stamp Date January 31, 2008 PDUFA Goal Date July 31, 2008 Reviewer Name(s) Yuliya Yasinskaya, M.D. PDUFA Target Goal Date is June 19, 2020. Heron resubmitted an NDA to the FDA for HTX-011 in September 2019 and the FDA set a PDUFA goal date of March 26, 2020. Our enhanced FDA calendar integrates PDUFA dates, clinical trial primary completion dates, and working capital runway estimates into a single timeline that covers all companies facing upcoming PDUFA dates. -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. Provention Bio, Inc. 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. In the submission, DURECT addresses the issues raised concerning POSIMIR in the FDA's complete response letter and requests approval of the analgesic drug. NESS ZIONA, Israel, Sept. 10, 2020 (GLOBE NEWSWIRE) -- … The FDA stated that the NDA resubmission is a complete, Class 2 response to the Complete Response Letter (CRL) issued in August 2019, and the FDA set a Prescription Drug User Fee Act (PDUFA) goal date of October 30, 2020 for the completion of its review of the NDA. The FDA set a PDUFA goal date of July 23, 2020. 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 … (risk/benefit, efficacy, labeling) Julie-Ann Crewalk, M.D. As described in the Sarepta Advisory Committee Briefing Document Addendum, the principal basis for establishing the effectiveness of eteplirsen is a comparison of patients in Study 201/202 to a historical control group. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of August 17, 2020. BOSTON, May 13, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity, today announced that the U.S. Food and Drug Administration (FDA… In addition, the Company today announced that it is updating and extending its cash runway guidance. (clinical trial safety) Eileen Navarro, M.D. No issues related to clinical efficacy or safety were noted. The sBLA for rilonacept was accepted for priority review by the FDA in November, with a PDUFA goal date of March 21. The goal of an RCT is to show that a new drug is superior to an existing standard of care (SOC) ... NDA for Translarna under FDA review has PDUFA date of October 24, 2017. 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. The FDA has deemed the resubmission a complete response to its June 2016 Complete Response Letter ("CRL") that requested additional information related to the dosing algorithm for the proposed label. A Marketing Authorisation Application (MAA) for HTX-011 was validated by the European Medicines Agency (EMA) in March 2019 for review under the Centralised Procedure. This publication provides an overview of what to expect from the FDA in 2019 based on established PDUFA dates. 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. The FDA granted priority review to the application and assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 21, 2021. As a result, the potential exists for the highest number of approvals since the mid‐90’s. Rilonacept is a weekly, subcutaneously-injected … The FDA has assigned a new Prescription Drug User Fee Act ("PDUFA") goal date of February 8, 2018. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 27, 2021. The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is July 21, 2020. "We developed JZP-258 to be a safer and long-term treatment option for patients.