Drugs
FDA has approved an Eton Pharmaceuticals and Azurity Pharmaceuticals NDA for Eprontia (topiramate) oral solution, 25mg/mL, indicated as a monotherapy for treating partial-onset or primary generalized tonic-clonic seizures in patients two years of age and older. It is also indicated as an adjunctive therapy for treating partial-
Devices
FDA has cleared a Magstim 510(k) for the Horizon 3.0, a transcranial magnetic stimulation (TMS) device designed for the clinical setting. The company says the device offers enhanced workflows with navigated TMS and analytics. It also features Magstim Connect, a patient data management system for TMS that is
FDA Policy/General
McKesson has signed a definitive agreement to purchase RxCrossroads, a provider of tailored services to pharmaceutical and biotechnology manufacturers, from CVS Health for $735 million. The acquisition is intended to enhance McKesson’s existing commercialization solutions for manufacturers of branded, specialty, generic and biosimilar drugs, including comprehensive patient support services,
FDA Policy/General
DEVICES FDA has cleared a Surgical Innovation Associates 510(k) for DuraSorb Monofilament Mesh, a line of bioabsorbable technologies for reconstructive and cosmetic surgery. “Much like an absorbable stitch, DuraSorb Monofilament Mesh is designed to integrate into the patient’s tissue – providing strong support during the critical initial phases of
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision for a guidance entitled “Postmarketing Adverse Experience Reporting and Recordkeeping for Drug and Biologics Products” (OMB Control Number 0910-0230). The collection supports statutory provisions regarding the monitoring of FDA-regulated products. The guidance was revised to provide
FDA Policy/General
Federal Register notice: FDA is amending the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during April, May, and June. The agency is also making available the basis of approval and environmental review documents, where applicable. To view the
Drugs
FDA has issued a seven-item Form FDA-483 to ACRX Specialty (Las Vegas, NV) after inspecting the firm in July and finding GMP issues. For example, FDA said the firm’s ISO 5-classified aseptic processing areas had visibly dirty equipment or surface areas. It also found non-microbial
Drugs
Pfizer plans to soon submit to FDA data as part of its ongoing rolling submission seeking an Emergency Use Authorization for the Covid-19 oral antiviral candidate, Paxlovid (PF-07321332; ritonavir), after new data showed it significantly reduced hospitalization and death. An interim analysis of 1,200 patients in the
Devices
FDA has granted ReWalk Robotics a breakthrough device designation for its ReBoot, a lightweight, battery-powered orthotic exo-suit intended to assist ambulatory functions in individuals with reduced ankle function related to neurological injuries, such as stroke. The device is a customizable and personalized for home and community use, according
Drugs
FDA’s Psychopharmacologic Drugs Advisory Committee 11/5 voted 12 to 1 that a Levo Therapeutics NDA for carbetocin nasal spray and its use for treating Prader-Willi syndrome (PWS) did not show significant evidence of effectiveness. The submission is seeking approval for the drug to treat PWS-related hyperphagia,
Drugs
FDA has approved a Tris Pharma NDA for Dyanavel XR (amphetamine), extended release once-daily tablets for treating attention-deficit hyperactivity disorder (ADHD) in patients six years and older. Approval was based on data showing that DyanaveL XR extended-release tablets were bioequivalent to the company’s Dyanavel XR extended-
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers. The document provides recommendations for implementing a pathogen reduction device when manufacturing pathogen-reduced blood components. To view the notice, click here.
Drugs
FDA has granted orphan drug designation for Menarini Group’s SEL24/MEN1703 to treat acute myeloid leukemia (AML). The drug is described as a first-in-class orally available dual PIM/FLT3 inhibitor that is being investigated in the DIAMOND-01 trial as a single agent for treating patients with
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Content of Premarket Submissions for Device Software Functions. The document is intended to provide information regarding the recommended documentation sponsors should include in premarket submissions for the agency to evaluate device software functions. To view the notice, click here.
Drugs
FDA says that as of 10/13, all manufacturers and labelers of isoxsuprine hydrochloride drug products agreed to cease distribution of the unapproved drugs. An agency online statement says that FDA announced on 7/15/20 a final decision of the commissioner that Vasodilan containing isoxsuprine HCl lacked substantial evidence,
Devices
FDA says it has uploaded a video, Cyber Vitals: Information for Patients’ Medical Device Health, with practical steps patients can take to protect their device and personal information. An agency statement (contains link to video) says as medical devices are more connected, devices may be exposed to cybersecurity risks. “FDA
Drugs
FDA has released the FDA-483 issued following a 5/3-5/21 inspection at Atlas Pharmaceuticals, a Phoenix, AZ, outsourcing facility. The three inspection observations were: * failing to establish, write, and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * determinations of conformance to
Devices
FDA has cleared a Flume Catheter Co. 510(k) for its Flume urinary balloon catheter. “When inflated, the Flume balloon envelops the tip of the catheter so that the emptying bladder makes contact with the flexible balloon surface rather than the rigid catheter tip,” the company says. “The drainage ports
Devices
Increasing the availability of over-the-counter (OTC) Covid-19 home tests is a top priority at FDA, according to acting commissioner Janet Woodcock. In 11/4 testimony provided to the Senate Health Education Labor & Pension Committee, Woodcock said the agency prioritizes the review of emergency use authorization (EUA)
Drugs
Covid-19 has led to an unprecedented number of new product submissions to FDA to help combat it. To date, there are more than 660 drug development programs in the planning stages and the agency has reviewed more than 470 trials of potential therapies, according to acting commissioner Janet Woodcock.
Drugs
A lengthy Reuters series on the U.S. battle against diabetes says the treatment goal to lower A1c below 7% pushed by makers of diabetes drugs is leading to cases of hypoglycemia that have significant adverse effects and can lead to death. “Pharmaceutical giants launched years-long marketing campaigns for
Devices
FDA has published a draft guidance, Content of Premarket Submissions for Device Software Functions, with information on the recommended documentation sponsors should include in premarket submissions for the agency’s evaluation of the safety and effectiveness of medical device software functions. When final, the document will replace a 5/11/