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FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas

Posted 9 days ago in Pharma Industry News

September 9, 2014 -- The U.S. Food and Drug Administration is reminding health care professionals and consumers about safety concerns with all sterile-use drug products made and distributed by Downing Labs LLC, doing business as NuVision Pharmacy, in Dallas, Texas. Health care professionals should not use any NuVision/Downing Labs sterile products for their patients because the firm cannot ensure the safety or quality of these products. Administration of a non-sterile drug product may result in...

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FDA allows marketing of the first test to assess risk of developing acute kidney injury

Posted 13 days ago in Pharma Industry News

September 5, 2014 -- Today the U.S. Food and Drug Administration allowed marketing of the NephroCheck test, a first-of-a-kind laboratory test to help determine if certain critically ill hospitalized patients are at risk of developing moderate to severe acute kidney injury (AKI) in the 12 hours following the administration of the test. Early knowledge that a patient is likely to develop AKI may prompt closer patient monitoring and help prevent permanent kidney damage or death. The kidneys...

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U.S. Marshals seize drug products from Flawless Beauty

Posted 2 weeks ago in Pharma Industry News

September 4, 2014 -- Various unapproved and improperly labeled drug products that were marketed, sold and distributed via the Internet by Flawless Beauty LLC, of Asbury Park, New Jersey, have been seized by U.S. Marshals at the request of the U.S. Food and Drug Administration and the U.S. Attorney for the District of New Jersey. These products, including injectable drug products, were marketed, sold and distributed to individuals, retail outlets, health spas and clinics. The seized products,...

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Monthly News Roundup - August 2014

Posted 2 weeks ago in Pharma Industry News

Belsomra: Merck’s First-in-Class Insomnia Treatment Approved The U.S. Food and Drug Administration (FDA) approved the long-awaited Belsomra (suvorexant) tablets for difficulty in falling and staying asleep (insomnia). Belsomra, in a new class called orexin receptor antagonists, blocks the action of orexin, a chemical involved in the sleep-wake cycle in the brain. The FDA has approved Belsomra in various 5 to 20 milligram (mg) strengths. Belsomra is taken once 30 minutes before bed with a...

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FDA takes action against Georgia dietary supplement manufacturer

Posted 3 weeks ago in Pharma Industry News

MONDAY August 25, 2014 -- A dietary supplement manufacturer is under a federal court order to stop illegally marketing its products as treatments for disease, and to terminate the sale of supplements until the company complies with the U.S. Food and Drug Administration’s manufacturing regulations and other requirements. A federal judge issued the injunction against BioAnue Laboratories of Rochelle, Georgia, and its owner/operators, Gloria and Kelly Raber. BioAnue’s products were sold as...

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DEA to Publish Final Rule Rescheduling Hydrocodone Combination Products

Posted 4 weeks ago in Pharma Industry News

August 21, 2014 -- On Friday the U. S. Drug Enforcement Administration (DEA) will publish in the Federal Register the Final Rule moving hydrocodone combination products (HCPs) from Schedule III to the more-restrictive Schedule II, as recommended by the Assistant Secretary for Health of the U.S. Department of Health and Human Services (HHS) and as supported by the DEA’s own evaluation of relevant data. The Federal Register has made the Final Rule available for preview on its website today at...

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FDA allows marketing of first ZnT8Ab autoantibody test to help diagnose type 1 diabetes

Posted 4 weeks ago in Pharma Industry News

August 20, 2014 -- Today, the U.S. Food and Drug Administration allowed marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that can help determine if a person has type 1 diabetes and not another type of diabetes. When used with other tests and patient clinical information, the test may help some people with type 1 diabetes receive timely diagnosis and treatment for their disease. Type 1 diabetes is the most common type of diabetes diagnosed in children and adolescents, but...

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Turkish man pleads guilty to importing illegal cancer drugs

Posted 4 weeks ago in Pharma Industry News

August 15, 2014 -- Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States. Akman pleaded guilty in the U.S. District Court for the Eastern District of Missouri, in St. Louis, Missouri, where he initially shipped his illegal drugs. The drugs did not meet the FDA’s standards and had not been approved for distribution in the United States. The FDA’s...

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FDA Warns Consumers About Fraudulent Ebola Treatment Products

Posted 4 weeks ago in Pharma Industry News

August 14, 2014 -- The U.S. Food and Drug Administration is advising consumers to be aware of products sold online claiming to prevent or treat the Ebola virus. Since the outbreak of the Ebola virus in West Africa, the FDA has seen and received consumer complaints about a variety of products claiming to either prevent the Ebola virus or treat the infection. There are currently no FDA-approved vaccines or drugs to prevent or treat Ebola. Although there are experimental Ebola vaccines and...

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Everything You Need to Know About Experimental Ebola Treatment ZMapp

Posted 6 weeks ago in Pharma Industry News

FAQ: Ebola Experimental Treatments & Vaccines This FAQ addresses questions the public has about potential treatments and vaccines for Ebola. This material has been cross posted on the CDC website. What is ZMapp? ZMapp, being developed by Mapp Biopharmaceutical Inc., is an experimental treatment, for use with individuals infected with Ebola virus. It has not yet been tested in humans for safety or effectiveness. The product is a combination of three different monoclonal antibodies that...

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Jazz Pharmaceuticals Completes Acquisition Of Rights To Defibrotide

Posted 6 weeks ago in Pharma Industry News

DUBLIN, Aug. 5, 2014 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the closing of its acquisition of rights to defibrotide in the United States (U.S.) and all other countries in the Americas from Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau). Jazz Pharmaceuticals now owns worldwide rights to defibrotide. Defibrotide is a novel product that is marketed by Jazz Pharmaceuticals in the European Union (EU) under the name Defitelio® for the treatment of severe hepatic...

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FDA takes steps to help ensure the reliability of certain diagnostic tests

Posted 7 weeks ago in Pharma Industry News

July 31, 2014 -- Today, the U.S. Food and Drug Administration took important steps to ensure that certain tests used by health care professionals to help diagnose and treat patients provide accurate, consistent and reliable results. First, the FDA is issuing a final guidance on the development, review and approval or clearance of companion diagnostics, which are tests used to identify patients who will benefit from or be harmed by treatment with a certain drug. Companion diagnostic tests are...

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Monthly News Roundup - July 2014

Posted 7 weeks ago in Pharma Industry News

GSK’s Flonase Allergy Relief Approved for OTC Use Roughly 50 million people in the U.S. suffer from nasal allergies. The U.S. Food and Drug Administration (FDA) has approved Flonase Allergy Relief (fluticasone propionate 50 mcg spray) as an over-the-counter (OTC) nasal spray for the symptoms of hay fever or upper respiratory allergies. Flonase Allergy Relief can be used for nasal and eye-related allergy symptoms, including runny and itchy nose, sneezing, congestion, and itchy and watery...

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FDA Commissioner's Statement on the Surgeon General’s Call to Action to Prevent Skin Cancer

Posted 7 weeks ago in Pharma Industry News

TUESDAY, July 29, 2014 -- Each year, thousands of Americans are diagnosed with some form of skin cancer. The Surgeon General’s Call to Action to prevent skin cancer is important especially during these hot summer months when many of us spend extra time in the sun. Over the last few years, the FDA has taken a number of important steps designed to help consumers better understand the harmful effects of exposure from the sun and from indoor tanning. Today, consumers going to a beach or...

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Boehringer Ingelheim: Benefits and Safety of Pradaxa Repeatedly Confirmed

Posted 8 weeks ago in Pharma Industry News

Ridgefield, CT, July 23, 2014 – Boehringer Ingelheim (BI) wants to set the record straight following misleading statements that the British Medical Journal (BMJ) published today regarding Pradaxa® (dabigatran etexilate mesylate). We are concerned that this publication may alarm patients and prompt them to stop taking Pradaxa, thereby increasing their risk of stroke. To be clear, many of the allegations made by BMJ were reported months ago in the media and have been previously addressed in...

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FDA announces voluntary nationwide recall of all non-expired sterile drugs from Unique Pharmaceuticals

Posted 8 weeks ago in Pharma Industry News

July 23, 2014 -- The U.S. Food and Drug Administration is alerting health care professionals and consumers of a voluntary recall of all non-expired drug products produced for sterile use by Unique Pharmaceuticals Ltd., of Temple, Texas. The recalled products include lot 86513, N-Acetyl Cysteine 20%, and all other non-expired, purportedly sterile drug products. Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from Unique...

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FDA Consumer Advice on Powdered Pure Caffeine

Posted 8 weeks ago in Pharma Industry News

July 21, 2014 -- The FDA is warning about powdered pure caffeine being marketed directly to consumers, and recommends avoiding these products. In particular, FDA is concerned about powdered pure caffeine sold in bulk bags over the internet. The FDA is aware of at least one death of a teenager who used these products. These products are essentially 100 percent caffeine. A single teaspoon of pure caffeine is roughly equivalent to the amount in 25 cups of coffee. Pure caffeine is a...

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Indictment of FedEx Corporation for Illegally Distributing Prescription Drugs

Posted 8 weeks ago in Pharma Industry News

July 17, 2014 -- The U.S. Attorney for the Northern District of California today charged the FedEx Corporation with conspiring with two separate but related online pharmacy organizations to distribute controlled substances and prescription drugs to U.S. consumers without requiring their customers to have a valid prescription, as required by the Federal Food, Drug, and Cosmetic Act. Agents from FDA’s Office of Criminal Investigations worked closely with the U.S. Drug Enforcement...

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Popping Pills in America: Can the DEA Fix This?

Posted 9 weeks ago in Pharma Industry News

There's no doubt about it - the United States is a big consumer of prescription painkillers. In fact, in 2010 enough prescription painkillers were prescribed to medicate each American adult every four hours for an entire month. A report released in March 2014 from the U.S. National Safety Council shows that prescription drug overdoses – more than car accidents – are the leading cause of accidental death among U.S. working-age adults. According to the Centers for Disease Control and...

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DEA: Placement of Tramadol Into Schedule IV

Posted 9 weeks ago in Pharma Industry News

July 11, 2014 -- The U.S. Drug Enforcement Administration (DEA) has announced tramadol has been placed into schedule IV of the Controlled Substances Act (CSA) effective August 18, 2014. The new scheduling applies to all tramadol salts, isomers, and salts of isomers. This action imposes the regulatory controls applicable to schedule IV controlled substances on persons who handle or propose to handle tramadol. The Controlled Substances Act (CSA) is the federal U.S. drug policy under which...

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