Drugs
FDA has approved Amgen/UBS’ Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of fracture. An agency statement says these are women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies.
Drugs
An FDA drug safety communication says the agency has received reports of serious harm in patients who are physically dependent on opioid medicines suddenly having the medicines discontinued or the dose rapidly decreased. Examples of the harm include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide, the communication says.
FDA Policy/General
FDA and the Federal Trade Commission (FTC) say Advanced Spine and Pain, Mount Laurel, NJ, which is doing business as Relieveus, is using the Internet to market its CBD Salve, CBD Oil, and CBD for Dogs, which FDA considers to be new, unapproved and misbranded human or animal drugs that
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Apollo Care Columbia, MO (3/20): FDA inspected the outsourcing facility 11/2018 and cited serious deficiencies in its practices for producing sterile drug products. For example, some of
Drugs
FDA has released the FDA-483 issued following a 2/22-3/1 inspection at Aurobindo Pharma, Telangana, India. The 11 specific observations on the form were: * failing to fully follow responsibilities and procedures applicable to the quality control unit; * failing to establish control procedures that monitor the output and
Devices
FDA has cleared an Aggredyne 510(k) for the AggreGuide A 100 ADP Assay testing cartridge, an in vitro diagnostic device used to measure the effect of various antiplatelet medications that target the platelet P2Y12 receptor. Clearance is based on clinical data using FDA-approved combinations of dual anti-platelet
Devices
FDA has issued a safety alert about online marketers selling pre-owned test strips or test strips not authorized for sale in the U.S. to consumers. The agency says the test strips may not be safe to use because they might not have been stored properly or their expiration
FDA Policy/General
Federal Register notice: FDA has announced a 5/14 Oncologic Drugs Advisory Committee meeting. In the morning session, the committee is scheduled to discuss a Daiichi Sankyo NDA for pexidartinib capsules, indicated for treating adult patients with symptomatic tenosynovial giant cell tumor. In the afternoon session, they will discuss Daiichi’
FDA Policy/General
Federal Register notice: FDA has announced a 5/7 Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting. Panel members are scheduled to discuss approaches to evaluate the effect of renal impairment on drug exposure, and best practice considerations for translating pharmacokinetic (PK) information into dose individualization instructions. To view the
FDA Policy/General
Federal Register notice: FDA has determined that Casper Pharma’s Antivert (meclizine hydrochloride) chewable tablets were not withdrawn from sale for reasons of safety or effectiveness. Antivert is indicated for treating vertigo associated with diseases affecting the vestibular system. The determination allows FDA to continue to approve ANDAs that refer
Devices
FDA has cleared a Spry Health 510(k) to market the Loop System, a clinical-grade wearable that measures pulse oximetry, respiration rate and heart rate. The device is intended to allow clinicians to remotely monitor their patients with chronic diseases, such as chronic obstructive pulmonary disease, according to the
Drugs
Bellerophon Therapeutics and FDA have reached agreement on the regulatory approval pathway for INOpulse, a proprietary pulsatile nitric oxide delivery system for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Based on recent data and INOpulse’s safety profile, Bellerophon says FDA agreed that it can measure
Drugs
FDA has approved a ViiV Healthcare NDA for Dovato (dolutegravir and lamivudine), as a complete regimen for treating human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato. The
FDA Policy/General
Final Guide on REMS Factors Federal Register notice: FDA makes available a final guidance entitled “Risk Evaluation and Mitigation Strategy: FDA’s Application of Statutory Factors in Determining When a Risk Evaluation and Mitigation Strategy Is Necessary.” 04/05/2019 Cortisporin Not Withdrawn Due to Safety/Efficacy: FDA Federal Register
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Risk Evaluation and Mitigation Strategy: FDA’s Application of Statutory Factors in Determining When a Risk Evaluation and Mitigation Strategy Is Necessary.” The document is intended to clarify how FDA applies factors in determining whether a risk evaluation and
FDA Policy/General
Federal Register notice: FDA determines that Monarch Pharmaceuticals’ Cortisporin (hydrocortisone/neomycin sulfate/polymyxin B sulfate) was not withdrawn from sale for reasons of safety or effectiveness. The determination allows FDA to approve ANDAs that reference the drug product as long as they meet relevant legal and regulatory requirements. Cortisporin is
FDA Policy/General
Federal Register notice: FDA has determined that Teva’s Qvar 40 and Qvar 80 (beclomethasone dipropionate HFA) inhalation aerosol products were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow the agency to approve ANDAs that reference the products if all other legal and regulatory
Biologics
Celgene has submitted a BLA for luspatercept, an erythroid maturation agent for treating adult patients with very low to intermediate risk myelodysplastic syndromes-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions. It is also seeking approval for treating adult patients with beta-thalassemia-associated anemia
Drugs
Jazz Pharmaceuticals, Lundbeck, and Alexion Pharmaceuticals have agreed to pay a total of $122.6 million to resolve allegations that they each violated the False Claims Act by illegally paying Medicare or Civilian Health and Medical Program co-pays for their own products through foundations that the companies used as
Drugs
FDA has posted a 24-page Form 483 from a 5/2018 inspection of Akorn’s Decatur, IL sterile drug manufacturing operation. The inspection documented “poor aseptic processing techniques” and the company’s inadequate system for monitoring environmental conditions in aseptic processing areas. Additionally, the inspection form cited Akorn for
FDA Policy/General
The Alliance for a Stronger FDA has submitted Congressional testimony that asks appropriators to increase President Trump’s FY 2020 budget proposal by 15% ($60 million) for an overall increase of $418 million. The $60 million boost should go towards food safety activities, the Alliance says, such as “enhanced funding
Devices
FDA has cleared an Avanos Medical 510(k) for its improved On-Q with Bolus pump for reducing postoperative opioid use to achieve pain management. The device is intended to provide “customized control for patients recovering from post-surgical pain by delivering continuous, non-opioid medication to the surgical site