Drugs
FDA has accepted an Oyster Point Pharma NDA for its OC-01 (varenicline) nasal spray to treat the signs and symptoms of dry eye disease. The agency assigned a PDUFA target action date of 10/17, the company says. It also says FDA currently does not plan to schedule an
Drugs
FDA has accepted for review an Eyenovia NDA for MydCombi (tropicamide 1% and phenylephrine 2.5%) ophthalmic solution, a fixed combination mydriatic (pupil dilation) agent for use in routine eye exams. “MydCombi was developed with the goal of providing a touchless fixed combination microdose formulation to improve the patient’s
Drugs
FDA 2/27 issued an emergency use authorization (EUA) to Janssen Biotech for its single intramuscular Covid-19 vaccine injection. The EUA follows an unanimous (22-0) advisory committee vote 2/26 (see earlier story). The company’s data “show that the vaccine’s known and potential benefits outweigh its
Devices
Medtronic is recalling (Class 1) its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit because the device may fail to initially start, restart, or have a delay in restarting after the pump was stopped. Such delays or failures to start or restart have occurred during pre-implant testing, during the
Drugs
In recognition of Rare Disease Day (2/28), FDA has announced new actions to advance development and approval of therapies to such diseases. For example, a new request for applications (RFA) has been posted within the agency’s Orphan Products Grants Program for “Efficient and Innovative Natural History Studies Addressing
Drugs
FDA has issued CorMedix a complete response letter on its NDA for DefenCath (taurolidine/heparin catheter lock solution) for use in kidney failure patients receiving chronic hemodialysis through a central venous catheter. The agency letter cited concerns at a third-party manufacturing facility after a review of records requested by
Drugs
FDA has accepted for review a Merck NDA for gefapixant, an investigational selective P2X3 receptor antagonist for treating refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. An RCC is a cough that persists despite appropriate treatment of underlying conditions, and a UCC is a cough where the
Drugs
Bristol-Myers Squibb and three U.S.-based Sanofi subsidiaries have been ordered to pay $834 million to the state of Hawaii over marketing and promotion violations involving Plavix, a blood thinner used to reduce the risk of serious cardiovascular events such as heart attacks, strokes and blood clots. Hawaii
Drugs
FDA has issued Athenex a complete response letter on an NDA for oral paclitaxel plus encequidar for treating metastatic breast cancer. The letter indicated concern about a safety risk due to an increase in neutropenia-related sequelae in patients on the oral paclitaxel arm compared with the intravenous paclitaxel arm
Devices
Empirical Spine says it will submit a rolling PMA for its LimiFlex Paraspinous Tension Band for treating patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The submission will be based on data from a pivotal trial comparing outcomes from patients who receive either LimiFlex or transforaminal lumbar interbody fusion
Devices
Medtronic has recalled all unused Valiant Navion thoracic stent grafts and informed physicians to immediately stop using the device until further notice due to reports from the Valiant Evo Global Clinical Trial indicating that three were observed to have stent fractures, two of which have confirmed Type IIIb endoleaks, and
Devices
FDA has granted a de novo marketing authorization to Q30 Sports Science for its Q-Collar, a device intended to be worn around the neck of athletes aged 13 years and older during sports activities to aid in protecting the brain from the effects associated with repetitive sub-concussive head
Drugs
FDA has approved an Amneal Pharmaceuticals ANDA for 150 mcg/day norelgestromin and 35 mcg/day ethinyl estradiol transdermal system, a generic copy of now-discontinued contraceptive Ortho Evra (Janssen Pharmaceuticals). As part of the approval, Amneal was granted 180 days marketing exclusivity. The product will be marketed under the
Drugs
FDA has approved B. Braun Medical’s acetaminophen injection in IV bags in 1,000 mg in 100 mL and 500 mg in 50 mL doses. The products are being manufactured using dual-sourced active pharmaceutical ingredients to reduce potential supply risks, the company says. Acetaminophen is indicated for managing
Drugs
FDA has asked Merck for additional data beyond a recently completed Phase 3 study of investigational Covid-19 drug MK-7110, an immune modulator. Previously, the company and the U.S. government penned a $356 million deal to supply the U.S. with 60,000 to 100,000 doses of
Biologics
An FDA advisory committee has voted 22-0 to support an emergency use authorization (EUA) for Janssen Biotech’s single intramuscular Covid-19 vaccine injection. In briefing materials released in advance of the meeting, agency reviewers determined that the vaccine “met the prespecified success criteria” in the pivotal trial. The
Biologics
GC Pharma has submitted a BLA for GC5107 (immune globulin intravenous (human),10% liquid) for treating patients with primary humoral immunodeficiency disease. The submission is based on data from a Phase 3 North America study that met its primary efficacy endpoint on the incidence rate of acute serious bacterial infections,
FDA Policy/General
Federal Register notice: FDA is amending its animal drug regulations to reflect the withdrawal of approval of seven new animal drug applications for lack of compliance with regulation-reporting requirements. They are: * Walco International’s Cuprate (cupric glycinate) * Oxis International’s Palosein (orgotein) * ConAgra Pet Products’ Sergeants Sure Shot (n-
Drugs
FDA has approved an AbbVie supplemental BLA for Humira (adalimumab) for treating moderately to severely active ulcerative colitis in pediatric patients five years of age and older. Approval was based on clinical trial (ENVISION I study) data showing that Humira induced clinical remission at week eight and maintained remission at
Devices
CDRH Office of In Vitro Diagnostics and Radiologic Health director Timothy Stenzel says that as of 2/17 FDA had authorized 331 tests and sample collection devices, including 247 molecular tests and sample collection devices, 70 antibody tests, and 14 antigen tests. Speaking at the 43rd CDRH virtual town hall
Drugs
A Consumer Reports (CR) investigation shows that FDA waited nine months in 2018 before warning the U.S. public about tianeptine, a dietary supplement that has opioid-like effects. The report says the magazine obtained FDA e-mails that “underscore concerns about FDA’s ability to police the $46 billion
Biologics
Former FDA chief of staff Lauren Silvis has been added to President Joe Biden’s Covid-19 response team. Silvis was agency chief of staff under former commissioner Scott Gottlieb. Before serving as chief of staff from 5/2017 to 6/2019, she was CDRH deputy director for policy. Silvis