FDA grants approval to Novo Nordisk chronic weight management drug
December 25th 2014FDA has approved the new drug application (NDA) for liraglutide [rDNA origin] injection (Saxenda, Novo Nordisk) , the first once-daily glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management.
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Proposed rule from FDA requires electronic prescription drug labeling
December 23rd 2014According to a rule proposed by FDA in the Federal Register (December 18, 2014), healthcare providers would receive prescription drug and biologics product labeling information via an electronic system, thus replacing the use of paper to provide such information on the safety and effectiveness of human prescription drugs.
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Despite risks in elderly, benzodiazepine use increases with age
December 23rd 2014Despite known risks of confusion and falls associated with benzodiazepine use in elderly patients, a study published in JAMA Psychiatry, finds that prescription of benzodiazepines increases as people age. The research offers the first estimates of use patterns in the United States.
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Link between Rx drugs and teen drug abuse: Study
December 22nd 2014One medical center is urging parents to seek non-medical solutions for their children’s anxiety or insomnia, after a recent study found that teens prescribed anti-anxiety or sleep medications are up to 12 times more likely to abuse prescription drugs than those who had never been prescribed them.
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FDA green lights combination antibiotic
December 22nd 2014FDA approved ceftolozane/tazobactam (Zerbaxa, Cubist Pharmaceuticals, Inc.) for the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by designated susceptible Gram-negative bacteria.
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FDA approves Viekira Pak to treat hepatitis C
December 19th 2014FDA has approved ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets (Viekira Pak, AbbVie) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.
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FDA approves first therapy for treating patients with GEP-NETs
December 18th 2014FDA has approved lanreotide (Somatuline Depot, Ipsen) Injection, 120 mg (referred to as Somatuline) for the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
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Novel new drugs approved in 2014
December 17th 2014FDA’s Center for Drug Evaluation and Research (CDER) reports that it has approved 35 novel new drugs in 2014. These 35 drugs include new molecular entities (NMEs) submitted to CDER in new drug applications (NDAs) and new therapeutic biologics submitted in biologics license applications (BLAs).
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HHS partners with 7-11 Inc. to promote open enrollment
December 16th 2014Customers at 7-11 stores who use a bill-paying system will receive information promoting the Affordable Care Act’s open enrollment period on their printed receipts, allowing HHS to reach financially underserved consumers.
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Naloxone price increases may threaten public safety
December 15th 2014A price increase for a popular form of the medication, naloxone, threatens the ability of non-profit programs and organizations, including police departments around the country, to provide a medical antidote for drug overdoses.
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