The US Food and Drug Administration (FDA) has added a boxed warning to the label for gout drug febuxostat (Uloric, Takeda) on the basis of results of a large post marketing safety study. The FDA has concluded that there is an increased risk for death with febuxostat compared to another gout medicine, allopurinol (multiple brands). “This conclusion is based on our in-depth review of results from a safety clinical trial that found an...
Tag: <span>FDA</span>
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Trump Administration Brags About Quick Generic Drug Approvals. But Hundreds Of Them Aren’t For Sale.
Meanwhile, brand-name drug makers are raising prices at 10 percent per year. The Trump administration has been trumpeting a huge increase in generic drug approvals by the Food and Drug Administration in the past two years, the result of its actions to streamline a cumbersome process and combat anti-competitive practices. But nearly half of those...
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Teva’s ProAir Digihaler FDA Approved to Monitor Asthma and COPD Treatment
Teva Pharmaceutical, based in Israel, landed the first FDA approval for a digital inhaler with built-in sensors. The ProAir Digihaler (albuterol sulfate 117 mcg) Inhalation Powder is indicated for people suffering from asthma & COPD as a way of preventing and treating bronchospasm, a tightening of the muscles that line the airways. The ProAir Digihaler...
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Certain antibiotics may cause aortic aneurysm, FDA warns
(CNN)The US Food and Drug Administration warned on Thursday that the benefits of fluoroquinolone antibiotics do not outweigh the risks — which include aortic aneurysm — for certain patients, according to the latest research. The research is based on reports of patient problems and on studies published between 2015 and 2018. Fluoroquinolone antibiotics are often...
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FDA casts shadow on hemp win, calling CBD products illegal
The hemp industry still has work ahead to win legal status for hemp-derived cannabidiol, or CBD oil, as an ingredient in food or dietary supplements despite the big farm bill President Donald Trump signed this week designating hemp as an agricultural crop. CBD oils have become increasingly popular in lotions, tinctures and foods, but their...
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FDA approves drugs for treatment of two rare blood diseases
(HealthDay)—Two drugs have been approved by the U.S. Food and Drug Administration for the treatment of rare blood diseases, the agency announced Friday. Elzonris (tagraxofusp-erzs) infusion was granted the first approval for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and children aged 2 years and older. Researchers investigated the efficacy of...
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GenMark Fungal Blood Culture Test Clears FDA
NEW YORK (GenomeWeb) – GenMark Diagnostics announced today it has received 510(k) clearance from the US Food and Drug Administration for a molecular diagnostic panel assay to detect fungal pathogens from blood cultures of patients with suspected blood stream infections. The test is called the ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel. It runs...
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FDA Accepts BrainStorm’s NurOwn® IND Application for Progressive Multiple Sclerosis
U.S. Phase 2 Study to Begin in First Quarter of 2019 NEW YORK, Dec. 17, 2018 — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application...
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FDA approves drug to treat rare immune disease
Gamifant is the first drug to be approved specifically for HLH. The drug’s efficacy was demonstrated in a clinical trial of 27 pediatric patients with suspected or confirmed primary HLH. Patients had refractory, recurrent, or progressive disease while being treated with conventional HLH therapy or were intolerant of conventional HLH therapy. Patients were a mean...
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FDA approves drug for treatment of travelers’ diarrhea
Travelers’ diarrhea affects an estimated 10 to 40 percent of travelers worldwide each year, according to an FDA press release. The highest-risk destinations are most of Asia, the Middle East, Africa, Mexico, and Central and South America. (HealthDay)—The U.S. Food and Drug Administration on Friday announced it has approved Aemcolo (rifamycin), an antibacterial drug indicated...