Drugs
Carestream Health has filed a 510(k) application seeking clearance for its Carestream OnSight 3D Extremity System that uses cone beam computed tomography (CBCT) technology to capture weight-bearing and other types of patient extremity images. The device is designed to offer high-quality, low-dose 3D imaging for use
Drugs
Sandoz says that FDA should deny a 12/16/15 AbbVie petition asking the agency to require specific criteria before designating any product as an interchangeable biologic. AbbVie had called on FDA to require: that interchangeability be established in each condition of use for which the reference product is licensed,
FDA Policy/General
Federal Register Notice: FDA submits a proposed collection of information, “Environmental Impact Considerations,” to the Office of Management and Budget. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Guidance on Reagents for Detection of Specific Novel Influenza A Viruses — 21 CFR Part 866,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. FDA issued an order classifying
FDA Policy/General
Federal Register Notice: FDA is announcing that it has received a petition requesting exemption from the premarket notification requirements for a method, metallic reduction, glucose (urinary, non-quantitative) test system in a reagent tablet format that is intended to measure glucosuria (glucose in urine). These test systems in a are
Devices
FDA has approved an Intersect ENT PMA supplement a for an expanded indication for its Propel mini steroid releasing sinus implant to treat patients undergoing frontal sinus surgery. The approval allows the company to market the device for implanting in the frontal sinuses, located behind the eyebrows. Previously, it was
Drugs
FDA has granted KemPharm a user fee waiver and refunded the $2.4 million fee it paid when submitting an NDA for KP201/APAP, an investigational immediate-release combination of its hydrocodone prodrug, KP201 (benzhydrocodone hydrochloride), and acetaminophen (APAP). The submission was given a priority review and a 6/9
Devices
FDA has cleared an Opsens 510(k) for the OptoWire II, an optical guidewire developed to measure fractional flow reserve to diagnose severity of coronary stenosis for guiding the treatment of patients with coronary artery disease. The next-generation device features a new design comprising a hydrophilic coating that the
Devices
FDA has cleared an ACell, Inc. 510(k) for its MicroMatrix device and its concurrent use with Cytal Wound Matrix or Cytal Burn Matrix devices. The micronized particulate form of ACell’s patented Urinary Bladder Matrix technology provides coverage of the wound bed, especially in irregular wounds. It provides a
Drugs
Sanofi and Regeneron say that the Phase 3 ODYSSEY ESCAPE trial evaluating Praluent (alirocumab) injection in patients with heterozygous familial hypercholesterolemia, whose cholesterol levels required chronic, weekly or biweekly apheresis therapy, met its primary endpoint. The companies say the trial demonstrated that patients who added Praluent to their existing treatment
Devices
FDA has cleared a Great Basin Scientific 510(k) for its Shiga Toxin Direct Test, a stand-alone molecular diagnostic for detecting Shiga toxin-producing E. coli (STEC) and the serotype O157 directly from a patient specimen. The test can be run on the Great Basin Analyzer, which also performs
Drugs
A new study in the British Medical Journal (BMJ) raises some doubt about a 2011 FDA drug safety alert on selective serotonin reuptake inhibitor citalopram and its association with QT prolongation at higher doses (see earlier story). The agency subsequently restricted the maximum dose to 20 mg for subgroups of
Drugs
AstraZeneca says that the SOCRATES trial that assessed the efficacy of Brilinta/Brilique (ticagrelor) compared with aspirin in patients with acute ischemic stroke or transient ischemic attack missed its primary endpoint of time to first occurrence of any event from the composite of stroke, heart attack, and death. “Fewer events
Drugs
Attorney Michelle Yeary (Dechert) says that a Utah federal court decision in a case involving Aventis’ Clomid demonstrates “clear evidence” that FDA would not have permitted a labeling warning sought by the plaintiff. Writing in an online blog post, Yeary says that Clomid has been approved by FDA and on
Drugs
FDA says that 10 potential signals of serious risks/new safety information were identified by the FDA Adverse Event Reporting System between 10/2015 and 12/2015. A chart lists the signals and FDA action. In the case of the potential for wrong drug error with calcium gluconate injection, FDA
Drugs
FDA and Mezzion Pharma Co. have come to terms on a special protocol assessment (SPA) for two Phase 3 clinical protocols for the company’s extended half-life phosphodiesterase type 5 inhibitor (PDE5i) udenafil and its use in adolescents with single ventricle congenital heart disease with Fontan physiology. Previously, the
Devices
FDA has cleared a Stimwave 510(k) for its StimQ Peripheral Nerve Stimulator (PNS) System for relieving severe intractable chronic pain of peripheral origin. The implant is placed next to peripheral nerve locations where pain is originating, according to the company. It wirelessly delivers small pulses of energy to electrodes
Drugs
FDA has approved a Teva NDA for Cinqair (reslizumab) and its use with other asthma medicines for the maintenance treatment of severe asthma in patients aged 18 years and older. It is indicated for patients who have a history of severe asthma attacks despite receiving their current asthma medicines, according
Drugs
Some 36 university professors from UCLA and other institutions in the U.S., Canada, and Australia say that the findings of a clinical trial of Sarepta’s eteplirsen to treat Duchenne muscular dystrophy “are sufficiently robust to support the proposed mechanism of action of eteplirsen, to provide a plausible explanation
Devices
A 10/19-10/23/15 FDA inspection at the Terumo Medical Corp. facility in Elkton, MD, found Quality System Regulation violations in the firm’s manufacturing of destination guiding sheaths for renal, carotid, and peripheral use. A 3/17 Warning Letter from the agency’s Baltimore District Office says
Drugs
FDA says it is requiring class-wide safety labeling changes for immediate-release (IR) opioid pain medications, including a new Boxed Warning about the serious risks of misuse, abuse, addiction, overdose, and death. An agency news release says that FDA also is requiring several additional safety labeling changes across all
Drugs
FDA has granted MediciNova a fast track designation for MN-166 (ibudilast) and its use in treating patients with progressive multiple sclerosis. MN-166 has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova licensed the drug from Kyorin Pharmaceutical for potential