Drugs
FDA has accepted for review a Biohaven Pharmaceutical Holding Co. 505(b)(2) NDA for BHV-0223, an investigational sublingual form of riluzole for treating patients with amyotrophic lateral sclerosis (ALS). Biohaven previously announced that the agency granted orphan drug designation for BHV-0223 in ALS. The company says BHV-
Devices
FDA has classified as Class 1 an Oscor recall of its TB Temporary Bipolar Pacing Leads due to connector separation that may cause a loss of pacing. The TB Leads are used by physicians to stimulate or pace the heart to increase heart rate. Temporary pacing leads are placed into
FDA Policy/General
Info Collection on Drug Labeling Content/Format Federal Register notice: FDA submits to OMB an information collection extension entitled “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products.” 11/21/2018 Teva Used Priority Voucher for Migraine Drug Federal Register notice: FDA announces an approval
Devices
The Medical Imaging and Technology Alliance says that it believes that FDA relied on inadequate data collection in reaching some of its conclusions in a report on the quality, safety, and effectiveness of servicing of medical devices. “It is impossible to provide a statistically valid analysis of the extent of
Devices
AdvaMed has submitted its comments to FDA on the agency’s draft guidance on consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals. The association provided FDA specific line-by-line comments.
FDA Policy/General
Federal Register notice: FDA has announced an approval for Teva’s Ajovy (fremanezumab-vfrm) injection for preventing migraine in adults under a redeemed priority review voucher. Such vouchers are awarded to sponsors of approved rare pediatric disease product applications that meet certain criteria. The agency is required to publish notice
Drugs
FDA has approved Pfizer’s Daurismo (glasdegib) tablets for use in combination with low-dose cytarabine to treat newly-diagnosed acute myeloid leukemia (AML) in adults age 75 or older or who have other chronic health conditions or diseases that may preclude use of intensive chemotherapy. An agency news release
Devices
CDRH has released a Medical Device Enforcement and Quality Report it says demonstrates that increased inspections of medical device manufacturers and a targeted risk-based approach leads to improved compliance. “As medical device manufacturing has become an increasingly global enterprise,” says CDRH director Jeffrey Shuren, “FDA has taken forceful action
Drugs
Mylan says a comprehensive restructuring and remediation plan is underway at its Morgantown, WV, drug manufacturing facility. Reference to the plan was included in the company’s comment on an FDA 11/9 Warning Letter that was based on observations at the plant in April. “The issues raised in the
Drugs
Bristol-Myers Squibb is finding fault with FDA for issuing a draft guidance on product identifiers under the Drug Supply Chain Security Act (DSCSA) close to the end of the enforcement discretion period. The company says that “manufacturers have been preparing for a number of years to comply with the
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products,” (OMB Control Number 0910–0572). To view the notice, click here.
Drugs
FDA has accepted for priority review a Daiichi Sankyo NDA for quizartinib for treating adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). The agency set a user fee review action target date of 5/25/2019. The NDA is based on results from the Phase 3 QuANTUM-
Drugs
FDA says Mylan Pharmaceuticals has recalled 15 lots of valsartan-containing products due to the presence of N-Nitrosodiethylamine (NDEA). The agency notice says that not all Mylan valsartan-containing products distributed in the U.S. are being recalled. The company is only recalling lots that tested positive for NDEA
Drugs
FDA has granted OBI Pharma an Orphan Drug Designation for OBI-888 for treating pancreatic cancer. OBI-888 is a first-in-class monoclonal antibody cancer immunotherapy targeting Globo H, a glycolipid antigen. A Phase 1 study is underway at the University of Texas M.D. Anderson Cancer Center in
FDA Policy/General
The FDA Webview newsroom is closed in observance of the Thanksgiving Day holiday in the U.S. It will reopen on Monday, November 26 and the next overnight email bulletin will be sent that night, dated November 27.
Drugs
FDA has approved an Elite Pharmaceuticals ANDA for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. The combination medication and is used to help relieve moderate to moderately severe pain. U.S. annual sales are about
Drugs
A 2/12-3/1 FDA inspection at Surmasis Pharmaceutical, Des Moines, IA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 11/6 Warning Letter says specific violations were: * failure of the firm’s quality control unit to review and approve all drug product
Devices
A 9/18-10/2 FDA inspection at American Contract Systems, Zelienople, PA, found Quality System Regulation violations in the firm’s operations as a medical device manufacturer and contract sterilizer of various surgical trays/kits for hospital use. An 11/6 Warning Letter says specific violations were: * failing to
Drugs
A new FDA drug safety alert is warning that when Novartis’ multiple sclerosis (MS) drug Gilenya (fingolimod) is stopped, the disease can become much worse than before therapy started. “This MS worsening is rare but can result in permanent disability,“ the agency says. In response, FDA has ordered a new
Drugs
Sen. Bernie Sanders (I-VT) and Rep. Ro Khanna (D-CA) say they will introduce at the start of the next Congress their Prescription Drug Price Relief Act to “significantly reduce prescription drug prices for Americans.” In a media statement (contains links to text and summaries of the Senate and
Drugs
FDA has approved an Elite Pharmaceuticals ANDA for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. The combination medication and is used to help relieve moderate to moderately severe pain. U.S. annual sales are about
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection entitled “Survey of Current Manufacturing Practices for the Cosmetics Industry.” The agency defines cosmetics as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting