Drugs
Lupin Pharmaceuticals has recalled one lot (# L600518, Exp 05/18) of Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol) 1 mg/0.02 mg chewable and ferrous fumarate 75 mg tablets due to a complaint about a packaging error. The company says the contraceptive blister pack, when rotated 180 degrees
Devices
FDA has cleared an OrthoAccel Technologies 510(k) for its AcceleDent Optima, an orthodontic device that directly connects patients and practices with usage monitoring, direct messaging and virtual rewards via the AcceleDent App, which can be downloaded from iTunes and Google Play. The third generation vibratory accelerated orthodontic device is
Drugs
FDA has denied a Mallinckrodt petition relating to the company’s Inomax without commenting on whether it will do any or all of the actions the company requested. The response lists the company’s petition requests as: * require that all future inhaled nitric oxide drug products and delivery systems be
Drugs
An online RealClear Health column by research assistant Jordan Reimschisel calls on FDA to increase support for drug innovation as its primary goal. The column says the goal that policy makers like Congress should pursue is to “create an environment in which innovation and entrepreneurship can thrive with as few
Devices
FDA says that a 4/17 Zimmer Biomet recall of 33 implantable spinal fusion stimulators is Class 1. The devices were recalled due to the potential of harmful chemicals that may be toxic to tissues and organs, according to an agency recall notice. The stimulator is used during spinal fusion
Drugs
FDA has approved the expanded use of Novartis’ Zykadia (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test. Zykadia first received accelerated approval in 2014 for patients
FDA Policy/General
Federal Register notice: FDA has announced a 7/28 Vaccines and Related Biological Products Advisory Committee meeting. Panel members will discuss and make recommendations on the safety and efficacy of a Hepatitis B Vaccine manufactured by Dynavax. FDA intends to make background material available to the public no later than
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision to “Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded.” Recently FDA revised its regulations at 21 CFR part 330 to add six hours to the agency’
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Braun Medical Irvine, CA (5/12): FDA inspected the firm in April and May and cited significant GMP violations with finished pharmaceuticals. For example, the firm’s quality control
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health.” The notice solicits comments on information voluntarily submitted to CDRH on actual or potential health risk concerns about a medical device or radiological
Drugs
FDA has issued Sunovion Pharmaceuticals a Complete Response Letter on its NDA for SUN-101/eFlow (glycopyrrolate), indicated for treating chronic obstructive pulmonary disease. The agency letter does not require Sunovion to conduct any additional clinical studies for approval according to the company, which added that it will work with
Drugs
FDA says that AstraZeneca is recalling one specific lot of its Brilinta (ticagrelor) 90 mg tablets 8-count physician sample bottles following reports that a professional sample bottle containing eight tablets of Brilinta also contained AZ’s Zurampic (lesinurad) 200 mg tablets. The agency notice says that unintentional dosing with
Drugs
FDA has cleared a Masimo 510(k) for a pediatric indication for its O3 regional oximetry with an O3 pediatric sensor. “Regional oximetry, also referred to as tissue or cerebral oximetry, may help clinicians monitor cerebral oxygenation in situations in which peripheral pulse oximetry alone may not be fully indicative
Drugs
Amgen is suing FDA for not accepting its study reports and denying six months of pediatric exclusivity for its Sensipar (cinacalcet), a management treatment for patients suffering from hyperparathyroidism. An online Life Sciences Intellectual Property Review report says Amgen claims in its filing that FDA is required to accept a
Drugs
A 4/18-5/11/16 FDA inspection at the B. Braun Medical facility in Irvine, CA, found repeat violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 5/12 Warning Letter from the agency’s Los Angeles District Office. Specific violations cited in the
FDA Policy/General
A 1/17-2/1 FDA inspection at Med-Pharmex, Pomona, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals in the firm’s manufacturing of animal drug products including sterile injectables, oral suspensions, ointments, creams, non-sterile injectables, and non-sterile topical ointments. A
Drugs
Belcher Pharmaceuticals is asking FDA to amend its sulfite warning requirement for sulfite-containing injectable epinephrine used in emergency situations “to remove misleading information and acknowledge the current availability of approved epinephrine products that do not contain sulfite.” Belcher produces a sulfite-free epinephrine injection. The company’s 5/25
Drugs
Officials of FDA, the European Medicines Agency, and Japan’s Pharmaceuticals and Medical Devices Agency agreed at a 4/26-4/27 meeting that some requirements for clinical studies for antibacterial agents for specific types of infections such as urinary and intra-abdominal infections could be harmonized. A meeting summary
FDA Policy/General
FDA Information Collections Approved by OMB Federal Register notice: FDA posts a list of information collections that have been approved by the Office of Management and Budget. 05/26/2017 Comments Sought on MedSun Reporting Requirements Federal Register notice: FDA seeks comments on an information collection extension on “Adverse Event
Devices
Pioneer anti-power morcellator activist Amy Reed, 44, died 5/24 from complications stemming from disseminated uterine cancer, reported the Cancer Letter 5/25. Reed was the wife of cardio thoracic surgeon Hooman Noorchasm, who took up her cause in a virulent multimedia campaign widely reported by the Wall Street
Drugs
The House Energy and Commerce Committee has asked for additional information from NIH to verify corrections and the resolution of clinical research compliance issues, including fungal contamination, uncovered during a 2015 FDA inspection at the Institute’s pharmaceutical development section (see earlier story). The unit eventually shut down its operations
Biologics
FDA has accepted for priority review a Kite Pharma BLA for axicabtagene ciloleucel for treating non-Hodgkin lymphoma. The submission is based on data from the ZUMA-1 Phase 2 trial in patients with refractory aggressive non-Hodgkin lymphoma. The trial met the primary endpoint of objective response rate (82%