Drugs
FDA says that MPM Medical, Mesquite, TX, is recalling one lot of Regenecare HA Hydrogel due to contamination with the bacteria Burkholderia cepecia. An agency notice says Regenecare HA Hydrogel is an over-the-counter product containing 2% lidocaine that is used topically for temporary relief of pain and itching
Drugs
FDA is alerting health care professionals about the risk of inadvertent intrathecal administration with tranexamic acid injection, which may result in serious life-threatening injuries, including seizures, cardiac arrhythmias, paraplegia, permanent neurological injury, and death. “In most of the cases reported to FDA, tranexamic acid injection was erroneously administered instead
Drugs
FDA has approved a Vanda Pharmaceuticals NDA for Hetlioz (tasimelteon) capsule and liquid formulations for treating adults and children with nighttime sleep disturbances associated with Smith-Magenis Syndrome (SMS). The rare neurodevelopmental disorder, which involves an “inverted” circadian rhythm, makes it extremely difficult for patients with SMS to sleep during
Drugs
FDA has approved an additional indication for Blueprint Medicine’s Gavreto (pralsetinib) to treat patients with advanced or metastatic RET-mutant and RET-fusion-positive thyroid cancer. The company says the accelerated approval expands the labeled instructions to include adult and pediatric patients age 12 or older with advanced or
Drugs
A 3/19/18-3/23/18 FDA inspection at West Coast Nuclear Pharmacy, Tampa, FL, found “serious deficiencies in your practices for producing sterile drug products, which put patients at risk.” A just-released 10/6 Warning Letter says that under current law, radiopharmaceuticals that are compounded by entities
Drugs
FDA says it is accepting research proposals focused on assessing the impact of extended-infusion of beta-lactam antibacterial drugs on the development of beta-lactam resistance and patient outcomes. Specifically, a notice (includes a link to the research announcement) says, the agency will prioritize research proposals focused on evaluating
Drugs
FDA has granted AlloMek Therapeutics an orphan-drug designation for its macrocyclic MEK kinase inhibitor, CIP-137401, for treating neurofibromatosis Type 1 (NF1). The drug has been tested in an established NF1 preclinical model and was found to reduce both absolute tumor numbers and the size of plexiform neurofibromas, the
Drugs
FDA has granted Mesoblast Ltd. a Fast Track designation for remestemcel-L for treating acute respiratory distress syndrome (ARDS) due to Covid-19 infection. The designation is based on clinical data from a pilot study of remestemcel-L under emergency compassionate use at New York’s Mount Sinai Hospital earlier
Drugs
The Association for Accessible Medicines (AAM) says an FDA draft guidance on failure to respond to an ANDA complete response letter (CRL) within the regulatory timeframe raises some questions for which the association is seeking further clarification from the agency. The association’s comment letter says the guidance says that
Drugs
A citizen petition submitted on behalf of Pharmaceutical Research and Manufacturers of America (PhRMA) calls on FDA and HHS to take several steps to stop the drug import program recently announced by the Trump administration. PhRMA was one of three groups that recently filed suit in federal court to block
Drugs
AbbVie says FDA should modify its draft guidance on using physiologically based pharmacokinetic (PBPK) analyses in biopharmaceutics applications for oral drug product development, manufacturing changes and controls, to include recommendations for PBPK model-based biowaivers or safe-space applications in cases where permeability is the limiting factor controlling the appearance
Drugs
An FDA 2/19-2/21 inspection at ForYou, Inc., Loris, SC, found significant violations of current good manufacturing practice (CGMP) regulations for dietary supplements, among other violations. A just-released 10/20 Warning Letter says several of the firm’s products are considered to be unapproved new drugs and
Drugs
FDA has approved Gallium 68 PSMA-11 (Ga 68 PSMA-11), the first drug for positron emission tomography imaging of prostate-specific membrane antigen positive lesions in men with prostate cancer. The approval was granted to UCLA and the University of California, San Francisco. An agency statement says Ga 68
Drugs
FDA has approved a Genentech supplemental BLA for Xolair (omalizumab) for the add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. “With Xolair, we observed significantly reduced nasal polyps and congestion symptoms in adults who had nasal
Drugs
Minerva Neurosciences says that following a meeting with FDA on the data package and readiness to support an NDA of its roluperidone to treat negative symptoms in schizophrenia, it is continuing its development and NDA activities. Minerva says it had asked the agency to confirm that data from a Phase
Drugs
FDA has made available a draft guidance on Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications. The document notes that elevated gastric pH by acid-reducing agents (ARAs) can affect the solubility and dissolution characteristics of ora lly administered drug
Drugs
FDA has approved a Rhythm Pharmaceutical NDA for Imcivree (setmelanotide) for chronic weight management (weight loss and weight maintenance for at least one year) in patients six years and older with obesity due to three rare genetic conditions: pro-opiomelanocortin (POMC) deficiency, proprotein subtilisin/kexin type 1 (PCSK1) deficiency, and
Drugs
FDA has launched the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program for novel drug development tool (DDT) developers. “ISTAND encourages development of DDTs that fall outside of the existing DDT qualification programs: biomarkers, clinical outcome assessments, and animal models for use under the Animal Rule,” an
Drugs
FDA has approved an Eiger BioPharmaceuticals NDA for Zokinvy (lonafarnib) for treating Hutchinson-Gilford Progeria Syndrome and processing-deficient Progeroid Laminopathies. The ultra-rare, genetic, premature aging diseases accelerate mortality in young patients, according to the company. Untreated children with Progeria die of heart disease at an average age of
Drugs
Purdue Pharma pleaded guilty in New Jersey federal court 11/24 to conspiracies to defraud the United States and violate the anti-kickback law. It previously had agreed to the imposition of the largest penalties ever levied against a drug company. The Department of Justice says the company pleaded guilty
FDA Policy/General
Three Covington & Burling attorneys say a stronger regulatory focus can be expected at FDA in the administration of president-elect Joe Biden. In an online post, the attorneys outline their expectations by Center and program. CBER and CDER * additional effort to promote generic and biosimilar competition; * supply chain and
Drugs
In a complete response letter, FDA has informed Liquidia Technologies that it cannot approve the company’s NDA for its LIQ861 (treprostinil) inhalation powder to treat pulmonary arterial hypertension. The company says FDA indicated a need for additional information and clarification on chemistry, manufacturing, and controls data on the drug