Drugs
FDA has denied a Zydus Pharmaceuticals (USA) 9/13/2023 petition asking the agency to take specified actions about indomethacin suppositories, 50 mg. Zydus is one of the manufacturers of this generic product. The petition asked that FDA: * ensure that the currently marketed reference standard for the suppositories approved under
Drugs
FDA has released the form FDA-483 issued following a 1/22-2/2 inspection at Eugia Pharma Specialties Limited, a sterile drug manufacturer in Sangareddy, Telangana, India. The nine inspection observations in the 26-page form were: * failing to establish and follow procedures designed to prevent microbiological contamination of
Drugs
FDA has approved an Eicos Sciences NDA for Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. The drug’s efficacy was established in an open-label, controlled trial involving 47 adults with severe frostbite, according to an FDA release. Patients
Drugs
FDA has released a final guidance entitled “Charging for Investigational Drugs Under an IND Questions and Answers.” The document outlines requirements in agency regulations that allow sponsors to charge for investigational drugs under an IND for both clinical trials and expanded access for treatment use. It supersedes FDA’s 2016
Drugs
The CDER Office of Scientific Investigations (OSI) completed 128 medical product-related clinical inspection summaries (consults) in support of user fee applications received from 24 of the 27 CDER clinical review divisions during Fiscal Year 2023. The OSI annual report says the consults resulted in 418 inspectional observations, 351 with
Drugs
CBER has issued a Standard Operating Policy and Procedure (SOPP), Section 505(o)(4) Required Safety Labeling Changes, as a guide for Center staff for requiring a Section 505(o)(4) safety labeling change. The document applies to NDAs and BLAs. The SOPP says that under the FDA Amendments Act
Drugs
After more than 12 years, FDA has approved a Public Citizen 8/7/2011 petition request for safety labeling changes for glucocorticosteroids administered orally and by injection. In its 2/8 response, the agency denied other petition requests. “In particular,” the response says, “we partially grant the request that FDA
Drugs
A 10/11-10/22/2022 FDA inspection at the Madhu Instruments Private Limited drug manufacturing facility in New Delhi, India, found that redacted drug products were adulterated in that they had been prepared, packed, or held under insanitary conditions in which they may have been contaminated with filth or
Drugs
An FDA review of records submitted by Ningbo Poplar Daily-Use, a manufacturer of over-the-counter drugs in Yinzhou, Ningbo, China, in response to an agency request, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 2/5 Warning Letter says specific violations were:
Drugs
FDA has approved an Ipsen Biopharmaceuticals NDA for Onivyde (irinotecan liposome) for use in combination with oxaliplatin, fluorouracil, and leucovorin for first-line treatment of metastatic pancreatic adenocarcinoma. Approval was based on data from the company’s NAPOLI 3 trial (NCT04083235), a large-scale study involving 770 patients who had
Drugs
FDA has posted Warning Letters issued to US Chem Labs in Miami, FL, and Synthetix Inc., doing business as Helix Chemical Supply in Bronx, NY, for introducing unapproved and misbranded semaglutide, tirzepatide, and Thymalin products into interstate commerce. The US Chem Labs letter says the company offers on its Web
Drugs
FDA has published a draft of the International Council for Harmonization E2D(R1) guideline Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Report, that has been released for comments. The document provides guidance on definitions and standards for post-approval individual case safety
Drugs
FDA has made available a draft guidance entitled “Use of Data Monitoring Committees in Clinical Trials.” The document provides recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be useful for trial monitoring, and the procedures and practices that should be considered to guide their
Drugs
FDA has accepted for priority review a Lykos Therapeutics NDA for midomafetamine capsules (MDMA) used in combination with psychological intervention for treating individuals with post-traumatic stress disorder (PTSD). The agency has set an 8/11 user fee review action target date. The submission is based on data from two
Drugs
FDA has made available a draft guidance entitled “FDA Advanced Manufacturing Technologies Designation Program,” which is intended to outline a framework to enhance the reliability and robustness of pharmaceutical manufacturing processes. “Advanced manufacturing can integrate novel technological approaches, use established techniques in an innovative way, or apply production methods in
Drugs
FDA has approved a Takeda NDA for Eohilia (budesonide oral suspension), indicated for treating eosinophilic esophagitis (EoE) in patients aged 11 years and older. The corticosteroid was approved based on efficacy and safety data from two multicenter placebo-controlled 12-week studies (Study 1 and Study 2) in patients with
Drugs
FDA has granted Disc Medicine an orphan drug designation for DISC-3405 for treating patients with polycythemia vera (PV). The investigational, anti-TMPRSS6 (Transmembrane Serine Protease 6, also known as Matriptase-2) monoclonal antibody is designed to increase hepcidin production and suppress serum iron, according to the company. Disc Medicine
Drugs
FDA has cleared a Fresenius Medical Care 510(k) for its 5008X Hemodialysis High-Volume System. “Unlike conventional high-flux hemodialysis, which primarily employs diffusion to remove small molecules and fluid from the blood, high-volume hemodiafiltration incorporates both diffusion and convection techniques to eliminate larger molecules and effectively manage
Drugs
FDA is issuing a final rule to amend its regulations about the use of master files for biological products. The agency describes a master file as a submission that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing
Drugs
A new ProPublica/Pittsburgh Post-Gazette article reveals that in the early days of the 2021 recalls by Philips Respironics of its troubled CPAP breathing machines, the company began touting new safety studies that found the foam used in the devices, which was breaking apart and being discharged into patients’
Drugs
Federal Register notice: FDA has determined that TerSera Therapeutics’ Qmiiz (meloxicam) orally disintegrating tablets, 7.5 mg and 15 mg, were not withdrawn for safety or effectiveness reasons. The determination will permit the agency to approve ANDAs that reference the product if all other legal and regulatory requirements are met.
Drugs
FDA has posted a six-item Form FDA-483 from a 9/2023 inspection at Sichuan Deebio Pharmaceutical Co. in Guanghan, Sichuan, China, documenting significant GMP deficiencies with the firm’s active pharmaceutical ingredient manufacturing. For example, the form took exception to Sichuan’s laboratory records not being completed contemporaneously