Drugs
CDER Office of Generic Drugs (OGD) Office of Research and Standards director Robert Lionberger says OGD has taken many steps to encourage the development of complex generic drugs (drugs that have complex active ingredients, dosage forms, routes of administration, or drug-device combinations). In an online post, Lionberger outlines the
Drugs
In a complete response letter for Sanofi’s sNDA for Aubagio (teriflunomide) for children and adolescents 10 to 17 years old with relapsing forms of multiple sclerosis, FDA said the data submitted were not sufficient to obtain approval of an indication in the pediatric population at this time. Sanofi says
Biologics
FDA has approved a Stratatech’s StrataGraft for treating adult patients with thermal burns containing intact dermal elements (remaining deep skin layers) for which surgical intervention is clinically indicated. StrataGraft is made from two kinds of human skin cells (keratinocytes and dermal fibroblasts) grown together to make a bi-layered
FDA Policy/General
Federal Register notice: FDA is correcting a 5/12 notice about the withdrawal of approval of 12 ANDAs from multiple applicants. That notice indicated that FDA was withdrawing the approval of ANDA 060164, Nystatin Ointment, held by Lederle Laboratories. However, the notice was published with an incorrect application number for
Drugs
FDA has extended for three months to 9/25 the PDUFA review action date for the Ascendis Pharma BLA for lonapegsomatropin to treat pediatric growth hormone deficiency. The agency determined that information submitted by the company for FDA review constituted a major amendment, necessitating the additional review time. Company officials
Drugs
The Department of Justice says a Florida grand jury charged five additional defendants for their roles in an alleged scheme to purchase and distribute millions of dollars in diverted prescription drugs. A department statement says 14 people have now been charged in the scheme. The 6/10 indictment charged the
Drugs
FDA says its review of a Web site at www.pharmacygeoff.md determined that the site is offering drug products for sale in the U.S. intended to mitigate, treat, prevent, diagnose, or cure Covid-19 and several other diseases such as lupus, rheumatoid arthritis, malaria, HIV, and hepatitis C.
Drugs
FDA has granted Cerevel Therapeutics a fast track designation for CVL-871, a selective dopamine D1/D5 partial agonist in development for treating dementia-related apathy. The company says that apathy is a “strong predictor of dementia progression and can lead to decreased quality of life, increased morbidity and mortality,
FDA Policy/General
Federal Register notice: FDA has announced a 7/14 meeting of its Medical Devices Advisory Committee’s Gastroenterology and Urology Devices Panel. The committee is scheduled to discuss, make recommendations, and vote on information on a TransMedics PMA for the Organ Care Liver System, indicated for the resuscitation, preservation, and
FDA Policy/General
Federal Register notice correction: FDA is correcting a 2/12/2018 Federal Register notice to revise the regulatory review period for Merck’s Bravecto (fluralaner), indicated for flea and tick prevention in dogs and cats. The notice is corrected as follows: FDA has determined that the applicable regulatory review period
Drugs
Viona Pharmaceuticals has recalled two lots of diabetes drug metformin HCl 750mg because the product was found to contain levels of human carcinogen nitrosodimethylamine (NDMA) impurities above acceptable daily limits. The product was manufactured by Cadila Healthcare (Ahmedabad, India) for U.S. distribution by Viona Pharmaceuticals, according to a recall
Drugs
Generic drug manufacturer KVK-Tech (Newtown, PA) and executives Murty Vepuri (defacto owner) and Ashvin Panchal (head of quality assurance) have been indicted on charges of defrauding FDA based on their alleged distribution of unapproved drugs as well as alleged efforts to mislead the agency and conceal information which could
Biologics
FDA has released more information concerning Janssen’s Covid-19 contaminated vaccine substance made at Emergent BioSolutions’ troubled contract manufacturing facility in Baltimore. Earlier this year, Emergent was found to have significant GMP deviations that led to an agreement to shut down operations until corrections are implemented (see earlier story)
Devices
Two facility inspections of Innova Medical Group that ended 4/9 have led to a 6/10 Warning Letter because the firm is marketing its SARS-CoV-2 Antigen Rapid Qualitative Test without marketing approval, clearance, or authorization from FDA. The agency also found that clinical data submitted in Innova’
Biologics
Gaithersburg, MD-based Novavax has announced that its recombinant nanoparticle protein-based Covid-19 vaccine demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. The study enrolled almost 30,000 participants across 119 sites
FDA Policy/General
Former FDA commissioner Stephen Hahn has joined Flagship Pioneering as chief medical officer of its preemptive medicine and health security initiative. Hahn resigned from FDA in January as the new administration took power. Prior to FDA, he was the Chief Medical Executive at MD Anderson Cancer Center. Flagship Pioneering is
Drugs
FDA has issued Avenue Therapeutics a second complete response letter on its NDA for an intravenous formulation of tramadol, indicated for treating patients in acute pain who require an opioid. The letter said that the delayed and unpredictable onset of analgesia with IV tramadol does not support its benefit as
FDA Policy/General
The Medicines Company says the Phase 3 clinical trial, TANGO 1, evaluating its antibiotic Carbavance (meropenem-vaborbactam) for treating complicated urinary tract infections, met FDA pre-specified endpoints by showing an overall success rate of 98.4%. The trial randomized 550 adults, it says, to receive either Carbavance via a
FDA Policy/General
Guide on Animal Antimicrobial Drugs 6/11/2021 Federal Register notice: FDA has made available a final guidance for industry (GFI) #263 entitled Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to Be Available as
FDA Policy/General
Federal Register notice: FDA has made available a final guidance for industry (GFI) #263 entitled Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to Be Available as Over-the-Counter. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection entitled “Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug.” The new research is intended to examine physicians’ perceptions and behavioral intentions about an unapproved new use of an
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices — 21 CFR Part 607” (OMB Control Number 0910-0052). The collection supports agency regulations that set forth procedures and requirements pertaining