The FDA has approved Newron Pharmaceuticals' Xadago, or safinamide, as an add-on drug for patients with Parkinson's disease. Xadago is indicated for patients who already take levodopa/carbidopa but experience "off" episodes in which the treatment is not effective.
The FDA has asked Pain Therapeutics to conduct two additional studies of Remoxy ER, or extended-release oxycodone capsules CII, before refiling the new-drug application for Remoxy ER. The studies, which are expected to be completed this year, include a clinical abuse potential study via the intranasal route of abuse and a nonclinical abuse potential study using household solvents.
Neurocrine Biosciences' Ingrezza, or valbenazine, has met the primary endpoint of a late-stage study in which the drug showed a statistically valid difference from baseline in the AIMS scale than placebo in the treatment of tardive dyskinesia. The FDA's PDUFA date for Ingrezza's marketing application is April 11.
The Government Accountability Office confirmed it will investigate the FDA's orphan drug program for potential abuses after three US senators requested the probe. The investigation, which is expected to begin in nine months, will include a request for a listing of drugs approved or denied orphan status by the FDA, an evaluation of whether reviews are consistent and an analysis of the FDA's ability to keep up with orphan drug applications.
The European Medicines Agency has provided positive guidance for Actinium Pharmaceuticals' Iomab-B for treatment of acute myeloid leukemia. The agency said the company's data from a late-stage study of the drug was sufficient for filing a marketing authorization application.
Health Canada has seized 10 unauthorized health products from British Columbia-based EPCA Shipping, which distributes products for Extreme Peptides, an online health products retailer. The agency said the products, which were labeled to contain prescription drugs for breast cancer, erectile dysfunction and respiratory diseases in horses, posed a serious health risk.
The FDA is investigating four cases of canine illness that may be related to ingesting high levels of beef thyroid hormone, which can cause increased thirst and urination, weight loss and elevated heart rate, among other issues. Three cases occurred after the dogs ate a canned variety of food made by WellPet, and one case involved a canned food manufactured by Blue Buffalo; certain lots under both brands have been recalled.
European regulators have given Masimo CE mark approval for noninvasive blood pressure measurements for its Rad-97 Pulse CO-Oximeter and connectivity hub. The device, which offers Masimo's upgradeable rainbow noninvasive blood constituent monitoring technology and measure-through motion and low perfusion set pulse oximetry in a compact standalone monitor configuration, allows for arterial blood pressure measurement for neonatal, pediatric and adult patients.
An updated guidance for lateral interbody fusion in the lumbar spine has been issued by the UK's National Institute for Health and Care Excellence supporting the clinical efficacy of NuVasive's eXtreme Lateral Interbody Fusion procedure. NuVasive said the guidance change was supported mostly by evidence gathered from peer-reviewed journal articles with 14 years of data from its XLIF procedure.
InVivo Therapeutics said its nonclinical studies module, the first of three modules required to complete a humanitarian device exemption submission, has been submitted to the FDA for its neuro-spinal scaffold. The company anticipates acceptance of the module in the third quarter and intends to present its manufacturing module to the agency in the second half of the year and its clinical module next year.
This second edition covers the regulation of the manufacturing, marketing, labeling, distribution and sale of tobacco products and reflects the impact of the final "deeming regulation" that brings all products as defined by statute under FDA jurisdiction, including electronic cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe tobacco and dissolvable tobacco products. Order your copy today.