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From:Science (Vol. 227) Peer-ReviewedSix months ago, the Reagan Administration appointed Frank E. Young, dean of the University of Rochester medical school, to be commissioner of the Food and Drug Administration (FDA), which has broad authority over the...
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From:Oncology (Vol. 21, Issue 9) Peer-ReviewedGPC Biotech announced that the Oncologic Drugs Advisory Committee (ODAC) for the US Food and Drug Administration (FDA) recommended (12-0) that the FDA should wait for the final survival analysis of the SPARC trial...
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From:MPR - Physician Assistants' Edition (Vol. 22, Issue 4)Impax announced that the Food and Drug Administration (FDA) has approved Methyltestosterone Capsules, the generic version of Valeant's Testred. Testred, a CIII controlled substance, is an androgen indicated in males...
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From:Nurse Practitioners' Prescribing Reference (Vol. 23, Issue 2) Peer-ReviewedThe FDA announced class-wide safety labeling changes for all immediate-release (IR) opioids. Changes include a new boxed warning about the serious risks of misuse, abuse, addiction, overdose, and death. The dosing...
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From:Nurse Practitioners' Prescribing Reference (Vol. 20, Issue 2) Peer-ReviewedThe FDA has approved Liptruzet (ezetimibe and atorvastatin; Merck) for the treatment of elevated low-density lipoprotein (LDL) cholesterol in patient with primary or mixed hyperlipidemia as adjunctive therapy to diet...
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From:MPR - Physician Assistants' Edition (Vol. 23, Issue 1)Impax announced that the Food and Drug Administration (FDA) has approved Guanfacine Extended-Release Tablets, the generic version of Shire's Intuniv. Intuniv is a central alpha-2A agonist indicated for the treatment of...
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From:Medical Product Outsourcing (Vol. 9, Issue 1)For medical device and in-vitro diagnostic (IVD) tool manufacturers that previously were unwilling or unable to market their products in Mexico, it may be time to reconsider. COFEPRIS (the Federal Commission for...
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From:Medical Product Outsourcing (Vol. 9, Issue 1)The U.S. Food and Drug Administration (FDA) has recommended stricter safety measures for cardiovascular defibrillators after years of increasing problems with the emergency medical devices. The tighter regulation is...
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From:Asian Hospital & Healthcare ManagementBoston Scientific Corporation (NYSE: BSX) has completed enrollment in the PREVAIL confirmatory study, designed to gain U.S. Food and Drug Administration (FDA) approval for the WATCHMAN Left Atrial Appendage (LAA)...
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From:Inside Counsel Breaking NewsByline: Ashley Post The battle between generic and brand-name drug companies has escalated. The latest litigation involves allegations that brand-name drug makers are refusing to sell product samples to...
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From:Clinical Psychiatry News (Vol. 41, Issue 2)The Food and Drug Administration approved 39 new drugs in 2012, making it the most prolific year for drug approvals since 2004 and marking a major increase over the 30 drugs approved in 2011. Drugs that won FDA approval...
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From:Skin & Allergy News (Vol. 44, Issue 2)Sunscreens that have proven their protective ability and feature updated, more consumer-friendly labeling are hitting store shelves, but they currently share space with older products that may not have passed muster...
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From:Future Virology (Vol. 8, Issue 4)Author(s): Sabrina Wai-Chi To 1 , Jonathan Hon-Kwan Chen 1 , Wing-Cheong Yam [*] 2 Keywords * determination; drug resistance monitoring; HIV-1 diagnostic assays; tropism; ultradeep sequencing; viral load...
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From:Internal Medicine News (Vol. 46, Issue 7)The Food and Drug Administration has approved canagliflozin, an oral, once-daily therapy for adult patients with type 2 diabetes. The drug will be marketed by Janssen Pharmaceuticals as Invokana. Canagliflozin is...
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From:Internal Medicine News (Vol. 46, Issue 8)In an eleventh-hour action that derailed the possibility of generic formulations of controlled-release oxycodone (OxyContin) from appearing on the U.S. market anytime soon, the Food and Drug Administration announced...
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From:Obesity, Fitness & Wellness WeekBy a News Reporter-Staff News Editor at Obesity, Fitness & Wellness Week -- Data detailed on Diet and Nutrition Disorders have been presented. According to news reporting originating from Toronto, Canada, by NewsRx...
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From:Internal Medicine News (Vol. 46, Issue 19)AT THE ECNP CONGRESS BARCELONA--Armodafinil, a drug with Food and Drug Administration approval to treat excessive dleepiness and narcolepsy, showed efficacy for improving concentration, energy, and appetite in a...
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From:Future Virology (Vol. 8, Issue 12)Author(s): Lynn A Paxton 1 Keywords * emtricitabine; HIV; HIV prevention; PrEP; tenofovir Despite remarkable advances in the fields of HIV treatment and prevention in the past decade, the most recent UNAIDS...
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From:Spectroscopy (Vol. 28, Issue 11)The United States Food and Drug Administration (FDA) and the National Institutes of Health (NIH), as part of an ongoing interagency partnership, have awarded a total of up to $53 million to fund tobacco-related research...
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From:Internal Medicine News (Vol. 47, Issue 5)The incidence of all meningococcal serotypes is in decline, except for the spike in serogroup B on college campuses. "Although we do not expect an increase in MenB outbreaks on college campuses, the CDC has recently...