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FDA issues complete response letter for Merck’s chronic cough treatment Pharmaceutical-Technology
January 26, 2022
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Merck’s (MSD) New Drug Application (NDA) for gefapixant to treat adults with refractory chronic cough (RCC) or unexplained chronic cough (UCC).
Avenue Therapeutics gets complete response letter from USFDA for IV Tramadol expresspharma
June 16, 2021
Avenue Therapeutics, focused on the development of intravenous (IV) tramadol for the US market, announced that it has received a second Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its New Drug Application ...
Avenue Therapeutics Receives Complete Response Letter from FDA for IV Tramadol americanpharmaceuticalreview
October 16, 2020
Avenue Therapeutics has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for IV tramadol.
BioMarin Receives CRL for Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A americanpharmaceuticalreview
August 21, 2020
BioMarin Pharmaceutical announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to the Company's Biologics License Application (BLA) for valoctocogene roxaparvovec gene therapy for severe hemophilia A.
Heron Receives CRL for HTX-011 for Postoperative Pain americanpharmaceuticalreview
July 08, 2020
Heron Therapeutics has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for HTX-011 for the management of postoperative pain.
DURECT Receives POSIMIR® CRL americanpharmaceuticalreview
July 18, 2019
DURECT announced the U.S. Food and Drug Administration (FDA) has acknowledged that the submission of DURECT's full response to the Complete Response Letter (CRL) it previously received from ...
Eton Provides Update on EM-100 Program americanpharmaceuticalreview
July 18, 2019
Eton Pharmaceuticals announced the U.S Food and Drug Administration (FDA) provided Eton’s partner with a Complete Response Letter (CRL) relating to the application for EM-100 ......
Glenmark Pharma says US FDA has issued CRL for Ryaltris expressbpd
June 27, 2019
The CRL cites deficiencies in the Drug Master File pertaining to one of the active pharmaceutical ingredients and in manufacturing facilities, the company said in a regulatory filing
Troubled Immunomedics now hit with CRL for breast cancer drug candidate fiercepharma
January 21, 2019
The troubles for troubled Immunomedics keep piling up. The New Jersey-based biotech, which has gone through a failed tie-up deal, boardroom cleansing and FDA Form 483 issues, today reported it has received a complete response letter from the FDA related t
GSK Receives CRL from FDA for Mepolizumab americanpharmaceuticalreview
September 11, 2018
GlaxoSmithKline received a complete response letter (CRL) from the FDA regarding its application for mepolizumab as an add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstr

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