Drugs
FDA has denied a Pharmaceutical Manufacturing Research Services (PMRS) 5/11 petition to stay the effective date of the approval of Inspiron’s Roxybond (oxycodone hydrochloride) with labeling claims pertaining to chronic use and abuse deterrence until the agency issues substantive written responses to two earlier PMRS petitions. The denial
Drugs
Federal Register notice: FDA is seeking comments on an information collection extension on the “Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.” The guidance includes recommendations for planning, notification, and documentation for firms that report postmarketing adverse events. The guidance
Drugs
Pfizer officials say they have submitted a corrective and preventative action plan to FDA on remediating GMP issues at Hospira legacy facilities, and significant progress is expected in 2018. Pfizer acquired Hospira in 2015 and it has struggled to bring troubled facilities into GMP compliance. Earlier this year, FDA sent
Drugs
In a 54-page report, the Lancet Oncology Commission builds on the work of the Cancer Moonshot blue ribbon panel to lay out a series of future research priorities. “To ensure that cancer research in the U.S. continues to be world-leading,” it says, “it is imperative that investment
Drugs
Members of the FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18-1 on 10/31 to recommend approval of Indivior’s RBP-6000 for treating opioid use disorder. The product is described as an investigational once-monthly injectable buprenorphine formulation in the Atrigel
Drugs
FDA has cleared a Luminex 510(k) for the ARIES Group A Strep Assay for detecting Streptococcus pyogenes from throat swab specimens using the ARIES System. The real-time polymerase chain reaction-based qualitative in vitro diagnostic test, is part of Luminex's respiratory testing menu that includes the
Drugs
A 6/5-6/9 FDA inspection at India’s Kim Chemicals Private Ltd. found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 10/16 Warning Letter. The inspection also determined that Kim Chemicals manufactures unapproved new drug and misbranded drug products, the
Drugs
A 5/8-5/12 FDA inspection at Accelerated Analytical Laboratories, Milwaukee, WI, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 10/18 Warning Letter. The letter says the inspection found that the firm failed to establish and document the accuracy, sensitivity,
Drugs
FDA says it will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The authorities are located in Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the UK. An FDA announcement says the recognition “marks an important milestone to successful implementation
Drugs
FDA has granted accelerated approval to AstraZeneca’s Calquence (acalabrutinib) for treating adults with mantle cell lymphoma who have received at least one prior therapy. The kinase inhibitor works by blocking an enzyme needed by the cancer to multiply and spread, according to an FDA release. Approval was based on
Drugs
The New Jersey attorney general and Division of Consumer Affairs is taking comments on a proposed rule to limit payments and gifts from drug manufacturers to licensed providers who are authorized to prescribe medications. Attorney Serra Schlanger (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that
Drugs
The Government Accountability Office (GAO) says HHS should better assess the effectiveness of its efforts to expand medication-assisted treatment (MAT) for opioid addiction. In a study report, GAO says HHS has implemented five key efforts since 2015 that focus on expanding access to MAT for opioid use disorders. There
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Accelerated Analytical Laboratories Milwaukee, WI (10/18): FDA inspected the firm in May and cited significant GMP violations with its finished pharmaceuticals. For example, the firm’s contract testing
Drugs
As part of the Trump Administration’s national public health emergency declaration against opioid abuse, FDA commissioner Scott Gottlieb says the agency is exploring how opioid drug products are packaged, stored and discarded. In an online post, he says public health could be improved if a short-term supply of
Drugs
FDA has cleared three antimicrobial susceptibility tests (ASTs) for determining the appropriate usage of Melinta Therapeutics’ Baxdela (delafloxacin), a fluoroquinolone indicated in adults for treating bacterial skin and skin structure infections caused by susceptible bacteria. The three ASTs that have been cleared are: Hardy Diagnostics’ Delafloxacin Antimicrobial Susceptibility Disk (HardyDisk)
Drugs
FDA has approved a Janssen Pharmaceuticals supplemental NDA for a 10 mg once-daily dose of Xarelto (rivaroxaban) for reducing the continued risk for recurrent venous thromboembolism (VTE) after completing at least six months of initial anticoagulation therapy. The approval is based on data from the EINSTEIN CHOICE clinical study
Drugs
FDA has published an International Council for Harmonization guidance entitled “E9 (R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.” The addendum presents a structured framework to link trial objectives to a suitable trial design and tools for estimation and hypothesis testing. It introduces the
Drugs
FDA says its lab findings again link Rugby Diocto’s oral liquid docusate sodium to Burkholderia cepacia. The contamination was confirmed in several bottles of Rugby Diocto (docusate sodium) oral liquid from lot No. 20351701 manufactured by PharmaTech (Davie, FL). The lot was collected by FDA in response to a
Drugs
FDA has accepted for priority review an AbbVie NDA for elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist for managing endometriosis with associated pain. The NDA is supported by data from randomized clinical trials involving nearly 1,700 women with moderate-to-severe endometriosis-associated pain. The company
Drugs
Legislation introduced by four congressional Democrats would direct HHS to negotiate with drug manufacturers for lower prices on covered Medicare Part D drugs. Rep. Lloyd Doggett (D-TX), the bill’s prime sponsor, says drug pricing in the U.S. “is a tangled mess, a knot that will take more
Drugs
FDA has approved a Tesaro supplemental NDA for Varubi (rolapitant) IV in combination with other antiemetic agents in adults for preventing delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic chemotherapy. Delayed nausea and vomiting can occur anytime between 25 and 120
Drugs
Achaogen has submitted an NDA for plazomicin, indicated for treating complicated urinary tract infections, including pyelonephritis and bloodstream infections due to certain Enterobacteriaceae in patients who have limited or no alternative treatment options. The submission includes data from the EPIC and CARE clinical trials which evaluated the safety and efficacy