Drugs
FDA’s Antimicrobial Drugs Advisory Committee has voted 9 to 6 against recommending approval for Bayer HealthCare Pharmaceuticals’ ciprofloxacin dry powder for inhalation for use in treating non-cystic fibrosis bronchiectasis. Panel members said they had concerns about inconsistent data, drug resistance and having met only one of four primary
Drugs
Pfizer subsidiary Greenstone has recalled multiple lots of diphenoxylate hydrochloride and atropine sulfate tablets because the products have the potential to be super potent or sub potent. They were distributed nationwide to wholesalers/retailers from 11/2016 through 6/2017. “The use of this product in patients with uncontrolled diarrhea
Drugs
FDA commissioner Scott Gottlieb says the agency is taking steps to improve certain drug shortages at hospitals caused by hurricanes that devastated Puerto Rico this summer. Presumably, the agency is reacting to concerns raised late last week by the American Hospital Association, which urged the agency to intervene and “expedite
Devices
FDA has issued a guidance, Unique Device Identification: Direct Marking of Devices, to assist industry, and particularly labelers, to understand agency requirements for direct marking of medical devices for unique device identification (UDI). The question-and-answer document defines some terms used in agency regulations on the UDI direct marking
Drugs
By unanimous consent, the Senate agreed 11/16 to a House bill leaving to FDA decisions for battlefield drugs and medical devices. The House adopted HR 4374, introduced by Rep. Greg Walden (R-OR) the day before the Senate vote. The bill is intended to correct a provision adopted by
Drugs
FDA has approved Genentech’s Gazyva (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma (Stage II bulky, III or IV). Approval is based on results from the Phase 3 GALLIUM study, which showed superior progression-free survival
FDA Policy/General
Federal Register notice: FDA has announced a 1/10/2018 Bone, Reproductive and Urologic Drugs Advisory Committee meeting. Panel members will discuss a Lipocine Inc. NDA for oral testosterone undecanoate capsules, seeking an indication for testosterone replacement in males for conditions associated with a deficiency or absence of endogenous testosterone:
FDA Policy/General
Federal Register notice: FDA has announced that an initial decision of the administrative law judge (ALJ) is now the final agency decision on refusing approval of a supplemental NDA for Mepergan Fortis capsules (meperidine HCl, promethazine HCl). The ALJ found that the product had not been shown to be supported
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “Best Practices for Convening a GRAS Panel.” The document covers agency recommendations for convening a generally recognized as safe (GRAS) panel of experts to independently evaluate whether available scientific data, information, and methods establish that the substance is safe
Drugs
The Government Accountability Office (GAO) says FDA implemented requirements for reviewing applications for sunscreen active ingredients within time frames set by the 2014 Sunscreen Innovation Act. The act contained a provision for GAO to examine FDA’s implementation. As an example of meeting time frames, GAO says FDA issued an
Drugs
FDA has approved Genentech’s Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII inhibitors. An FDA announcement says that Hemlibra is a first-in-class therapy that works by bridging other
Drugs
FDA has approved Pfizer’s Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of kidney cancer returning after a kidney has been removed. “This is the first adjuvant treatment approved for patients with renal cell carcinoma, which is significant because patients with
Drugs
FDA has accepted an Alkermes NDA for aripiprazole lauroxil nanocrystal dispersion (ALNCD) as an add-on therapy with its Aristada (aripiprazole lauroxil) extended-release injectable suspension for treating schizophrenia. The agency has set a 6/30/2018 user fee review target action date for the submission. “If approved, administration of
Drugs
Former CDER Office of Process & Facilities director Robert Iser has joined Parexel as vice president of regulatory consulting services, where he will help clients avoid market delays due to compliance or quality problems. Iser spent more than 15 years at the agency. Most recently, he was responsible for reviewing
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” The document discusses changes in policies and procedures surrounding the user fee assessment and collection for biosimilar manufacturers. To view the notice, click here.
Devices
FDA has cleared a Voluntis 510(k) for Insulia, a “digital companion” for people with Type 2 diabetes that the sponsor says can integrate Lilly’s Basaglar and Novo Nordisk’s Tresiba insulin products. According to the company, this now makes Insulia available for people using any brand of basal
Drugs
Public Citizen is petitioning FDA to withdraw from the market all medications containing the angiotensin II receptor blocker (ARB) olmesartan medoxomil (Daiichi Sankyo’s Azor, Benicar, Benicar HCT, and Tribenzor, with all generics of these drugs). The advocacy group petition says that olmesartan medoxomil is associated with a risk of
FDA Policy/General
The National Antimicrobial Resistance Monitoring System (NARMS) annual report for 2015 says that while overall resistance remains low for most human infections and there have been measurable improvements in resistance levels in some important areas, the system is “closely monitoring a few areas of concern.” An agency news release says
Devices
The Federal Trade Commission (FTC) has finalized a consent order it says is designed to remedy the anticompetitive effects resulting from Abbott’s $8.3 billion acquisition of Alere. Under the order, the parties will divest two of Alere’s point-of-care medical device product lines — point-of-care
Drugs
Baxter International has recalled one lot of Nexterone (amiodarone HCl) 150 mg/100 mL premixed injection due to the potential presence of particulate matter which may have entered the solution during the manufacturing process, a recall notice says. “The particulate matter was identified by Baxter during a stability study, and
Drugs
A Phase 3 study by Acorda Therapeutics of tozadenant for Parkinson’s disease could be in jeopardy after the company reports five deaths in the study and recommending increased frequency (weekly) of blood cell count monitoring for trial participants. The increased monitoring is in response to cases of agranulocytosis, possibly
Drugs
An FDA drug safety alert says that Takeda’s gout drug Uloric (febuxostat) may have an increased risk of heart-related death when compared to allopurinol (Mylan’s Aloprim and Casper Pharma’s Zyloprim). This is the preliminary finding from an FDA-required safety study conducted by Takeda. “Once the