Drugs
A 3/26-3/30/18 FDA inspection at Newton Laboratories, Conyers, GA, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. A 4/23 Warning Letter says the violations also included misbranded new drugs and unapproved new animal drugs. Specific violations identified in the letter were:
Drugs
FDA says it is aware of recent incidents that caused excess radiation exposure to patients due to user error with certain systems used to produce rubidium Rb 82 injection for use with positron emission tomography (PET) myocardial perfusion imaging scans. An agency online notice says FDA is requiring safety labeling
Drugs
FDA has approved a Vertex Pharmaceuticals’ supplemental NDA for Kalydeco (ivacaftor) to expand its use in children with cystic fibrosis (CF) ages six months to less than 12 months who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to the drug
Drugs
FDA has approved an AbbVie supplemental NDA for Mavyret (glecaprevir and pibrentasvir) tablets to expand treatment in all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17. Previously, the product was approved to treat HCV in adults. Expanded approval was based on safety and efficacy data
Drugs
FDA has approved Becton Dickinson’s BD ChloraPrep skin preparation with sterile solution, a chlorhexidine gluconate antiseptic. The company says it uses a proprietary and patented process to sterilize the antiseptic solution inside the sealed ampoules located in the BD applicator. “With the new sterilization process in place, the BD
Drugs
FDA says it is requiring that a Boxed Warning be added to prescribing information and the Medication Guides for Lunesta (eszopiclone), Sonata (zaleplon), and Ambien, Ambien CR, Edular, Intermezzo, and Zolpimist (zolpidem) regarding rare but serious injuries that have happened involving sleepwalking, sleep driving, and engaging in other activities while
Drugs
The European Medicines Agency (EMA) says FDA has confirmed the capability of Bulgaria and Cyprus to carry out good manufacturing practice inspections at a level equivalent to the U.S. The two countries were included in the mutual recognition agreement between the European Union and the U.S. for inspections
Drugs
FDA has accepted for priority review a Bayer NDA for darolutamide for treating non-metastatic castration-resistant prostate cancer (nmCRPC). The submission is based on data from the Phase 3 ARAMIS trial in men with nmCRPC. Darolutamide is an investigational, non-steroidal androgen receptor (AR) antagonist with what the company
Drugs
FDA has revamped its “Product-Specific Guidances for Generic Drug Development” Web page to add new functionality, including text searching for active ingredient or reference-listed drug/reference standard products, filtering search results, and easier navigation. The Web page now allows users to filter search results using a text search
Drugs
Public Citizen has filed a lawsuit in DC federal court against FDA over a 2016 citizen petition that the agency has not acted on that sought a boxed warning on dopamine agonist medications, which can allegedly cause compulsive or uncontrollable behaviors. The petition sought labeling changes to six drugs that
Drugs
FDA has approved CSL Behring’s four- and five-gram vial sizes for Zemaira [alpha1-proteinase inhibitor (human)], its therapy for treating Alpha 1 Antitrypsin Deficiency. Previously, Zemaira was available only in a one-gram vial, and the new sizes reduces the number of vials necessary for reconstitution, the company
Drugs
FDA has announced a joint meeting 6/11-12 of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee to discuss safety concerns about safe prescribing and use of higher-range opioid doses. The agency is interested in learning more about how health
Drugs
FDA has approved the use of GlaxoSmithKline’s Benlysta (belimumab) intravenous (IV), a B-lymphocyte stimulator-specific inhibitor, in children aged five years and older with lupus. This is the first time that FDA has approved a treatment for pediatric patients with systemic lupus erythematosus (SLE), a serious chronic disease
Drugs
Writing in the Journal of the American Medical Association, former FDA commissioner Robert Califf and former Centers for Medicare and Medicaid Services acting administrator Andrew Slavitt say the “most promising path toward a fair system” of prescription drug pricing is what they term value-based payments. They write that “encouraging
Drugs
FDA has chosen Pew Charitable Trusts drug regulatory policy expert Elizabeth Jungman as Office of Regulatory Policy director, effective in July. At Pew since 2014, Jungman oversees initiatives related to antibiotic innovation, prescription drug safety, over-the-counter medicines, and other consumer health care products. Before joining Pew, she was
Drugs
Gilead Sciences says its Phase 3 STELLAR-3 study, which evaluated selonsertib in patients with bridging fibrosis due to nonalcoholic steatohepatitis (NASH), missed the primary endpoint. Selonsertib is an investigational small molecule inhibitor of ASK1, a protein that promotes inflammation, apoptosis and fibrosis in settings of oxidative stress, according to
Drugs
FDA has approved an Ortho Dermatologics NDA for Duobrii (halobetasol propionate and tazarotene) lotion, 0.01%/0.045%, indicated for the topical treatment of plaque psoriasis in adults. The company says that when used separately to treat psoriasis, halobetasol propionate’s (a corticosteroid) use duration is limited by FDA labeling
Drugs
The Department of Justice says Astellas Pharma and Amgen have agreed to pay $124.75 million to resolve allegations they each violated the False Claims Act by illegally paying Medicare copays for their own products through purportedly independent foundations that the firms used as conduits. The government says the Astellas
Drugs
Eli Lilly is withdrawing Lartruvo (olaratumab) from the market based on data from a confirmatory trial in which the drug did not improve survival for patients. Results from ANNOUNCE, a Phase 3 study of Lartruvo (olaratumab), in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma, did
Drugs
Federal Register notice: FDA has made available a final guidance entitled “Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles.” The document was prepared in response to requests from states asking the agency what would be necessary to provide confidence that stockpiled doxycycline has retained its original quality
Drugs
FDA has published a guidance, Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles, to help government public health and emergency response stakeholders determine if stockpiled doxycycline tablets and capsules have retained their purity and potency beyond the manufacturer’s labeled expiration date so the replacement of stockpiled
Drugs
FDA has published a draft guidance, Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes, to give the agency’s recommendations for adjusting for covariates in randomized clinical trials with continuous endpoints that are appropriate for analysis with normal-theory methods, such as the two-