The FDA has approved Lannett's buprenorphine and naloxone sublingual tablets as a treatment for opioid dependence. The drug is a generic version of Suboxone Sublingual Tablets and will be available in 2 mg/0.5 mg and 8 mg/2 mg dosage strengths.
Windtree Therapeutics' Aerosurf, or lucinactant for inhalation, has received fast-track designation from the FDA as a treatment for respiratory distress syndrome in premature infants. The drug is in a Phase IIb trial of premature infants with a gestational age of 26 to 32 weeks.
The FDA has accepted for review Puma Biotechnology's new-drug application for PB272, or oral neratinib, as a treatment for early-stage HER2-amplified breast cancer patients who received prior treatment with Roche Holding's Herceptin, or trastuzumab. A decision from the agency is expected by July 21 of next year.
TherapeuticsMD's new-drug application for Yuvvexy, or 17 beta-estradiol, has been accepted for review by the FDA for the treatment of dyspareunia in postmenopausal women. The agency's target action date for the NDA is May 7, 2017.
Bristol-Myers Squibb's type II variation application for Opdivo, or nivolumab, has been validated by the European Medicines Agency. BMS is seeking expanded approval for the drug as a treatment for locally advanced unresectable or metastatic urothelial carcinoma in patients who experienced disease progression after platinum-based chemotherapy.
The European Medicines Agency's Committee for Medicinal Products for Human Use has endorsed the approval of Janssen's Stelara, or ustekinumab, an interleukin-12/23 inhibitor. The treatment is recommended for moderate to severe active Crohn's disease in adults who are intolerant to, no longer respond to or did not have an adequate response to a tumor necrosis factor alpha antagonist or conventional therapy, or for those who cannot take such treatments because of medical contraindications.
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About 82 pounds of beef flank steak, hot Italian sausage and ground lamb products are being recalled by Colville, Wash.-based Gallo Meats after the Department of Agriculture's Food Safety and Inspection Service found that the products were uninspected but had the USDA mark of inspection applied to their packages. The recalled products, which were packed in 12- to 16-ounce Cryovac packages, were sold in Washington state, bear the establishment number "EST. 09334" inside the USDA mark of inspection and were produced between April 20 and July 27, 2016.
European regulators have granted Boston Scientific CE mark approval for its Lotus Edge transcatheter aortic valve system, which is designed for use in patients with severe aortic stenosis who have a high risk for surgical valve replacement. The system, which builds on the company's Lotus Valve System, features the Adaptive Seal technology for minimizing leaking and comes with a more flexible and narrower catheter for facilitating delivery.
European regulators have given ViewRay CE mark approval for its MRIdian Linac technology, an advanced linear, accelerator-based, MRI-guided radiation therapy system that is based on the company's first-generation MRIdian system. The system uses cobalt with linear accelerator technology and is available in the US for nonclinical research use.
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