FDA Policy/General
Federal Register notice: FDA has announced a 12/11 public meeting entitled “Drug Development Tool Process under the 21st Century Cures Act and PDUFA VI.” The meeting is intended to fulfill commitments made under the recently reauthorized Prescription Drug User Fee Act and the 21st Century Cures Act by soliciting
Drugs
FDA has accepted for review a Retrophin NDA for a new formulation of its Thiola (tiopronin) tablets for treating cystinuria. The agency has set a user fee review action target date of 6/30/2019. The 505(b)(2) NDA was submitted by the company’s partner, Mission Pharmacal. Thiola
Drugs
FDA has accepted for priority review an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) 150 mg tablets twice daily as a maintenance treatment in patients with newly-diagnosed, BRCA-mutated advanced ovarian cancer who are in complete or partial response following first-line standard platinum-based chemotherapy. A user
Devices
Sen. Judiciary Committee chairman Chuck Grassley (R-IA) has stepped up pressure on FDA after a recent HHS Inspector General (OIG) report said FDA should take steps to have its policies and procedures better address medical device postmarket cybersecurity risks. OIG found that FDA’s policies and procedures were insufficient
Drugs
FDA has granted Palvella Therapeutics a fast track designation for its lead product candidate PTX-022 (rapamycin topical formulation) for treating pachyonychia congenita (PC), a rare, chronically debilitating and lifelong monogenic disease. With PC, mutations of genes responsible for keratin production lead to dysregulated keratinocyte proliferation, increased skin fragility and
Drugs
Pain Therapeutics has appealed an August-issued FDA complete response letter (CRL) for Remoxy, an abuse-deterrent, extended-release form of oxycodone. The agency and the company have agreed to meet 1/31/2019 to discuss the action. According to the company, the CRL said data submitted in the company’
FDA Policy/General
Axiron Not Withdrawn Over Safety/Efficacy Federal Register notice: FDA determines that Eli Lilly’s Axiron (testosterone) transdermal metered solution, 30 mg/1.5 ml actuation was not withdrawn for safety or effectiveness reasons. 11/08/2018 Pilot Survey to Assess Allergy to Cosmetics Federal Register notice: FDA seeks comments
Devices
FDA has issued Chembio Diagnostic Systems an emergency use authorization for its DPP Ebola Antigen System, a rapid, single-use test for the detection of Ebola virus (Zaire ebolavirus). The fingerstick test uses a portable battery-operated reader, which can help provide clear diagnostic results outside of laboratories and in
Drugs
U.S. Sens. Chuck Grassley (R-IA) and Amy Klobuchar (D-MN) have sent a letter to the President urging him to support legislation to limit anticompetitive “pay-for-delay” pharmaceutical settlements between brand and generic drug makers as part of the Administration’s effort to bring down prescription drug
Drugs
After several years of planning, FDA says it implementing its “New Inspection Protocol Project (NIPP)” to modernize inspections with a “new way of assessing, recording and reporting the data from surveillance and pre-approval inspections for sterile drug products. FDA commissioner Scott Gottlieb says the “new tool is being applied
Drugs
Sandoz has recalled one lot of losartan potassium and hydrochlorothiazide after an impurity, NDEA (N-nitrosodiethylamine), was detected in the active pharmaceutical ingredient. The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen
Drugs
FDA approved a record number of generic drugs in October as part of its efforts to improve patient access to lower cost drugs. It approved 110 generic drugs and tentatively approved 18 others, for a total of 128 approval actions. This included 23 first generics for brands that lacked competition
Drugs
On FDA’s orders, U.S. marshals have conducted a mass seizure of FDA-regulated products that the agency says were being held under insanitary conditions that exposed them to widespread rodent, insect and live animal infestation. The 11/7-8 seizure at J and L Grocery (Alma, AK) included
Drugs
FDA has approved a Theravance Biopharma and Mylan NDA for Yupelri (revefenacin) inhalation solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The long-acting muscarinic antagonist is the first once-daily, nebulized bronchodilator approved for treating COPD, according to the companies. Approval was based on
Drugs
FDA has approved a new over-the-counter (OTC) version of Primatene Mist, a metered-dose inhaler indicated for providing temporary relief of symptoms of mild intermittent asthma. An earlier OTC version of the drug was withdrawn from the market in 2011 because it contained chlorofluorocarbon propellants, which are known
Drugs
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says FDA regulation of some medical devices as drugs violates the distinction Congress has drawn between the two regulatory schemes. “FDA’s position that it may regulate devices as drugs is plainly not authorized under the Federal Food, Drug, and Cosmetic Act (FFDCA)
Drugs
FDA has granted Korea-based Vivozon a fast track designation for VVZ-149, a non-opioid pain killer. The new mechanism-based non-narcotic and non-NSAID analgesic, according to the company, has demonstrated robust pain-suppressing efficacy in a panel of in vivo models (post-operative, formalin-induced, or
Drugs
FDA says it is updating the agency Expanded Access Web pages to improve usability through streamlining of content and a more user-friendly organization. A statement from FDA commissioner Scott Gottlieb says the updates include a reduction in duplication and the addition of new pages with commonly requested information such
Drugs
Former Pfizer Global Research and Development president John LaMattina says that while cardiovascular outcome trials for diabetes drugs are expensive and lengthy, they are here to stay. Writing in a Forbes online post, LaMattina says that Type 2 diabetics generally have conditions that make then prone to cardiovascular disease and
Devices
FDA says it has cleared a new Monteris Medical NeuroBlate probe containing a non-metallic fiber optic temperature sensor to address unintended probe heating in the magnetic resonance environment. The new probe replaces the metallic thermocouple temperature sensor of the original probe that was the subject of an agency 3/
FDA Policy/General
Federal Register notice: FDA has determined that Eli Lilly’s Axiron (testosterone) transdermal metered solution, 30 mg/1.5 ml actuation was not withdrawn for safety or effectiveness reasons. Axiron was initially approved in 2010 for replacement therapy in males for conditions associated with a deficiency or absence of endogenous
Drugs
FDA has granted Revive Therapeutics an orphan drug designation for cannabidiol for preventing ischemia and reperfusion injury (IRI) resulting from solid organ transplantation. IRI can result in a higher incidence of acute and chronic rejection, as well as long-term morbidity and mortality, the company says. Revive believes that cannabidiol’