FDA letter date archive
FDA Letters in 2020
Browse FDA approval and complete response letters issued or posted in 2020. This archive groups source-linked letters by issue or posting date so regulatory teams can review decisions and deficiency patterns over time.
| Letter | Type | Date | Agency / Product | Status |
|---|---|---|---|---|
Complete Response Letter InnoPharma Licensing LLC (Dec 22, 2020) FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Nonclinical evidence, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA ACETAMINOPHEN | Closed |
Complete Response Letter Novartis Pharmaceuticals Corporation (Dec 18, 2020) FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA LEQVIO | Closed |
Complete Response Letter scPharmaceuticals Services, Inc (Dec 3, 2020) FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Device constituent and human factors, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA FUROSCIX / FUROSCIX READYFLOW (AUTOINJECTOR) | Closed |
Complete Response Letter Zhejiang Novus Pharmaceuticals Co. Ltd. (Nov 27, 2020) FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA VANCOMYCIN HYDROCHLORIDE | Closed |
Complete Response Letter Genentech, Incorporated (Nov 23, 2020) FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA XOFLUZA | Closed |
Complete Response Letter Alkermes, Inc. (Nov 13, 2020) FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA LYBALVI | Closed |
Complete Response Letter Bioverativ USA, Inc. (Nov 13, 2020) FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA ENJAYMO | Closed |
Complete Response Letter sanofi-aventis U.S. LLC (Nov 12, 2020) FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA FEXINIDAZOLE | Closed |
Complete Response Letter Supernus Pharmaceuticals, Inc. (Nov 6, 2020) FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA QELBREE | Closed |
Complete Response Letter CMP Development LLC (Oct 16, 2020) FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Safety and adverse events, Bioequivalence and pharmacokinetics. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA ATORVALIQ | Closed |
Complete Response Letter Mallinckrodt Hospital Products IP Limited (Sep 11, 2020) FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Labeling, packaging, and proprietary name, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA TERLIVAZ | Closed |
Complete Response Letter Nobelpharma Co., Ltd. (Aug 13, 2020) FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA HYFTOR | Closed |
Complete Response Letter DBV Technologies S.A. (Aug 3, 2020) FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Device constituent and human factors, Safety and adverse events, Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA FDA-regulated product | Open |
Complete Response Letter Corium, Inc. (Jul 23, 2020) FDA's complete response letter contains source-text evidence related to Bioequivalence and pharmacokinetics, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA ADLARITY | Closed |
Complete Response Letter Heron Therapeutics, Inc. (Jun 26, 2020) FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Nonclinical evidence, Safety and adverse events, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA ZYNRELEF KIT | Closed |
Complete Response Letter Esteve Pharmaceuticals, S.A. (Jun 15, 2020) FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA SEGLENTIS | Closed |
Complete Response Letter Althera Life Sciences, LLC (May 26, 2020) FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA ROSZET | Closed |
Complete Response Letter Par Sterile Products, LLC (May 18, 2020) FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Nonclinical evidence, Safety and adverse events, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA MICAFUNGIN | Closed |
Complete Response Letter Xellia Pharmaceuticals, ApS (Mar 20, 2020) FDA's complete response letter contains source-text evidence related to Nonclinical evidence, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA VANCOMYCIN | Closed |
Complete Response Letter Braintree Laboratories, Inc. (Mar 13, 2020) FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA SUTAB | Closed |
Complete Response Letter Shilpa Medicare Limited (Mar 10, 2020) FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Chemistry, manufacturing, and controls, Bioequivalence and pharmacokinetics. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA BORTEZOMIB | Closed |
Complete Response Letter Hikma Pharmaceuticals USA Inc. (Feb 28, 2020) FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Device constituent and human factors, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA KLOXXADO | Closed |
Complete Response Letter Recordati Rare Diseases Inc. (Jan 28, 2020) FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, Bioequivalence and pharmacokinetics. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA CYSTADROPS | Closed |
Complete Response Letter Ingenus Pharmaceuticals, LLC (Jan 14, 2020) FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA CYCLOPHOSPHAMIDE | Closed |
Complete Response Letter Sarfez Pharmaceuticals Inc. (Jan 10, 2020) FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter. | CRL | Issued | US FDA SOAANZ | Closed |