Drugs
Generic drug stakeholders have recommended regulatory science research topics for FDA to pursue in Fiscal Year 2019. The Association for Accessible Medicines suggests: orally inhaled products, in-vitro methods, biowaivers, global reference product, CQAs, human factors considerations for sameness, identifying in-vitro alternatives to clinical endpoint studies, assessment of suitability
Drugs
Members of the FDA Anesthetic and Analgesic Drug Products Advisory Committee and the agency’s Drug Safety Advisory Committee have voted 14-3 to recommend that FDA not approve Pain Therapeutics’ Remoxy ER (oxycodone extended-release capsules) for management of pain severe enough to require daily, around-the-clock, long-
Drugs
FDA has released the FDA-483s issued following an agency 3/26-3/30 inspection at one Galaxy Surfactants manufacturing facility in Tarapur, India, and a 3/19-3/23 inspection at a second manufacturing facility in the same city. Observations from the first report were: * responsibilities and procedures applicable
Devices
FDA has permitted the de novo marketing of Fresca Medical’s Curve Positive Airway Pressure delivery system for treating obstructive sleep apnea. The device includes a dedicated flow generator, a lightweight and ergonomic air delivery hose, and a nasal pillow patient interface. According to Fresca Medical, it features the company’
Devices
FDA has cleared a Beckman Coulter Diagnostics 510(k) for its new high-sensitivity troponin assay, Access hsTnI, for use on the Access 2, DxI and all Access immunoassay systems. The assay is intended to detect troponin I, a protein that is present in circulation during myocardial infarction. The test
Drugs
FDA has released the FDA-483 issued to Exela Pharma Sciences, a Lenoir, NC, outsourcing facility, following a 9/19-9/28/17 inspection. Specific observations on the form were: * failing to handle and store components and drug product containers at all times in a manner to prevent contamination; * aseptic
FDA Policy/General
Public Citizen says FDA should immediately require the removal from the market of all medications containing the widely prescribed xanthine oxidase inhibitor febuxostat (Takeda’s Uloric) because (1) febuxostat increases the risk of death compared with alternative therapies and (2) there exist other effective medications that had been approved by
Drugs
FDA has granted Revive Therapeutics an orphan drug designation for cannabidiol (CBD) for treating autoimmune hepatitis (AIH), a rare disease that causes inflammation to the liver. The current standard of care is the use of steroids alone or steroids combined with azathioprine, which can cause severe treatment-related side effects
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval a proposed information extension for “State Enforcement Notifications” (OMB Control Number 0910-0275). FDA’s regulations authorize a state to enforce certain sections of the FD&C Act within its own jurisdiction. However, before doing so, a state must provide
Drugs
Global Blood Therapeutics say it is in discussions with FDA about accelerated approval for its voxelotor to treat sickle cell anemia based on results from Part A of its Phase 3 HOPE (Hemoglobin Oxygen Affinity Modulation to Inhibit HbS PolymErization) study that showed a statistically significant increase in the proportion
Drugs
FDA has accepted for priority review a Jazz Pharmaceuticals supplemental NDA seeking revised labeling for Xyrem (sodium oxybate) oral solution, to include an indication to treat cataplexy and excessive daytime sleepiness in pediatric narcolepsy patients. The user fee review action target date is 10/27. Xyrem is currently indicated for
Drugs
As a result of prescription drug user fees and company consulting and other payments to doctors who testify before FDA advisory committees, the agency has become more industry partner than regulator, speeding drugs to market faster than any other regulatory agency, according to a lengthy report from ProPublica. “FDA is
Drugs
FDA commissioner Scott Gottlieb says the agency will publish on its Web site in the coming weeks a list of surrogate endpoints that were the primary basis of approval or licensure of a drug or biological for both accelerated and traditional approvals. In a 6/25 speech to the National
Drugs
FDA has approved an Achaogen NDA for Zemdri (plazomicin) for adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options. However, the agency issued a complete response letter that refused to approve the drug for treating bloodstream
Drugs
A 12/11-12/14/17 FDA inspection at two Henan Lihua Pharmaceutical facilities in Henan, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients. A 6/12 Warning Letter says specific deviations were: * failure of the firm’s quality unit to review and approve all
Drugs
FDA has accepted for priority review a Genentech NDA for baloxavir marboxil, a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older. The agency set a user fee review action target of 12/24. “Baloxavir marboxil has been shown in clinical trials to decrease the
FDA Policy/General
Federal Register notice: FDA has announced a 7/26 Antimicrobial Drugs Advisory Committee meeting. Panel members are scheduled to review Agenda: The committee will discuss a 60 Degrees Pharmaceuticals NDA for tafenoquine tablets, 100 mg, for the proposed indication of preventing malaria in adults for up to six months of
Drugs
FDA has accepted for review a Merck supplemental BLA for Keytruda, an anti-PD-1 infusion treatment for use as adjuvant therapy for patients with resected, high-risk stage melanoma. The submission is based on data from the Phase 3 EORTC1325/ KEYNOTE-054 trial that showed a significant benefit in
Drugs
FDA has just released the FDA-483 containing six observations from a 9/5-9/14/16 inspection at Mylan’s finished drug manufacturing facility in Maharashtra, India. The specific observations were: * failing to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods; * failing to thoroughly review
Drugs
FDA released its latest updated list of medication guides with three new guides and 22 updated documents. New medication guides were issued for buprenorphine and naloxone subligual film, Nocdurna, Ferring’s Nocdurna (desmopressin), and Novartis’ Zortress (everolimus). Updated medication guides were issued for Cerecor’s Aciphex Sprinkles (raberprazole sodium) and
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Henan Lihua Pharmaceutical Co. Henan, China (6/12): FDA inspected the firm 12/2017 and cited significant GMP deviations for active pharmaceutical
Devices
FDA has approved a Glaukos Corp. PMA for the iStent inject Trabecular Micro-Bypass System, indicated for reducing intraocular pressure in adult mild-to-moderate primary open-angle glaucoma patients undergoing concomitant cataract surgery. The device is designed to “optimize the natural physiological outflow of aqueous humor by creating two