Drugs
FDA is asking the Isotretinoin Products Manufacturers Group (IPMG) to consider a potential temporary solution to help resolve issues patients, prescribers, and pharmacies are experiencing with the implementation of the modified iPLEDGE risk evaluation and mitigation strategy (REMS). An agency document says issues include an inability to log in to
Drugs
FDA says its review of a Web site maintained by Amcyte Pharma, Kirkland, WA, determined that the company offers Nasitrol for sale in the U.S. to mitigate, prevent, treat, diagnose, or cure Covid-19 in humans. A 1/3 Warning Letter says Nasitrol is an unapproved and misbranded drug
Drugs
FDA has granted AbbVie a breakthrough therapy designation for telisotuzumab vedotin (Teliso-V) and its use in treating patients with advanced/metastatic epidermal growth factor receptor wild type, nonsquamous non-small cell lung cancer (NSCLC) with high levels of c-Met overexpression whose disease has progressed on or after platinum-
Drugs
FDA has classified as Class 1 a recall by Medtronic’s Covidien unit of its Puritan Bennett 980 Ventilator Series System due to a manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. Customers have been told
Drugs
The New Jersey federal court has ordered Natural Solutions Foundation and its two principals to stop distributing unapproved and misbranded “nano silver” products promoted as a treatment for Covid-19. A Department of Justice statement says the company operated various Web sites to promote its products that purportedly contained silver
Drugs
FDA has approved Coherus BioSciences’ Yusimry (adalimumab-aqvh), a biosimilar form of AbbVie’s Humira (adalimumab). The American Journal of Managed Care reports it is indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn's disease, and ulcerative colitis. Yusimry is the seventh Humira
Biologics
FDA has published a draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, with recommendations for sponsors, investigators, and other interested parties on the use of digital health technologies for remote data acquisition from participants in clinical investigations evaluating medical products. The document defines a digital health
Drugs
University of Minnesota researchers have submitted an emergency use authorization application for fluvoxamine (Luvox and others), a generic antidepressant that they believe could be used as a Covid-19 treatment. MedPage Today reports that the researchers have been investigating fluvoxamine and other repurposed drugs. They said they prepared the application
Drugs
FDA has placed a clinical hold on 10 Gilead trials studying injectable versions of its experimental HIV treatment lenacapavir. Endpoints News reports that the agency expressed concerns that vials made of borosilicate glass could lead to the formation of sub-visible glass particles in the solution. Gilead CEO Merdad Parsey
Drugs
FDA says its laboratory testing of Impacta Health Hand Sanitizer manufactured by Guangzhou Shiruoni Cosmetics Co., Guangzhou, Guangdong, China, determined that it was adulterated and misbranded. A 12/7 Warning Letter says the hand sanitizer is adulterated due to violations of Current Good Manufacturing Practice (CGMP) requirements and misbranded because
Drugs
Janssen has submitted its bispecific teclistamab to FDA seeking an indication to treat patients with relapsed or refractory multiple myeloma. (Bispecific agents are able to bind to two antigens at the same time.) Fierce Biotech reports that Phase 1 studies showed a solid response rate in heavily treated patients. Last
Drugs
IMC Wash-Free Hand Sanitizer, declared to be manufactured by Guangdong Kemei Pharmaceutical Technology Co., Shishan Foshan, China, is an unapproved new drug that is adulterated and misbranded, according to a 12/14 FDA Warning Letter. The letter says the sanitizer is adulterated because it is labeled to contain 75%
Drugs
FDA has issued an emergency use authorization (EUA) for Merck’s molnupiravir for treating mild-to-moderate coronavirus disease in adults with positive results of direct SARS CoV-2 viral testing who are at high risk for progressing to severe Covid-19, including hospitalization or death, and for whom alternative
Drugs
Citing a possible defective delivery system, Padagis US has recalled three lots of nitroglycerin lingual spray in 12 g spray bottles. The company says “there is a remote risk that the product may not properly dispense medication to patients in the event of a malfunction of their dispensing unit.” The
Drugs
FDA issued a 12/22/21 emergency use authorization for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for treating mild-to-moderate Covid-19 in adults and children age 12 and older with positive results of direct SARS-CoV-2 testing who are at
Drugs
FDA has tentatively approved an Amphastar ANDA for vasopressin injection, 20 units/mL, 1 mL single-dose vial, indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. BioSpace reports that the agency determined that the Amphastar product is bioequivalent and therapeutically equivalent
Drugs
FDA has accepted an Amylyx Pharmaceuticals NDA for its AMX0035, an experimental therapy to address pathways leading to neuronal cell death in Alzheimer’s patients. The agency set a 6/26 PDUFA target date to act on the NDA, reports MedCity News. The agency granted the NDA priority review and
Drugs
FDA has granted fast track designation for Celularity’s CYNK-001, described as a novel on-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer cell therapy for treating patients with acute myeloid leukemia. The company says CYNK-001 previously received orphan drug designation for malignant gliomas and
Drugs
FDA has approved Novartis’ Cosentyx (secukinumab) to treat active psoriatic arthritis in patients age 2 and older and for active enthesitis-related arthritis in those age 4 and older. The company says Cosentyx is the first biologic indicated for enthesitis-related arthritis and the only biologic agent approved for both
Drugs
FDA has granted a fast track designation to lecanemab, BioArctic AB and Eisai’s investigational anti-amyloid beta protofibril antibody to treat early Alzheimer’s disease. The drug was granted breakthrough therapy designation in 6/2021. Eisai started a rolling BLA submission for lecanemab under the accelerated approval pathway in
Drugs
FDA has approved Novartis’ Leqvio (inclisiran) injection as a treatment to be used with diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of low-density lipoprotein cholesterol. An agency statement says Leqvio is approved at a 284
Drugs
FDA has approved Lilly’s Rezglovar (insulin glargine-aglr), a second approved biosimilar to Sanofi’s insulin glargine, indicated to improve glycemic response in children and adults with Type 1 diabetes and adults with Type 2 diabetes. Lilly says Rezglovar is available as a 3 ml prefilled KwikPen to be