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Weekly Drug News Round-Up: August 31, 2016

FDA Approves Erelzi: Sandoz’s Biosimilar For Enbrel

Erelzi is the third biosimilar approved in the US market Read More...

The U.S Food and Drug Administration (FDA) has approved Sandoz's Erelzi (etanercept-szzs), a biosimilar for Enbrel. Erelzi is the first approved biosimilar for etanercept, and is used for the same five indications found on Amgen’s reference product Enbrel: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. It’s important to note that Erelzi has been approved as a biosimilar, not as an interchangeable product. Physicians must write the prescription specifically for Erelzi, as pharmacists cannot automatically substitute Erelzi for Enbrel. Other approved US biosimilars are Sandoz’s Zarxio (filgrastim-sndz) and Pfizer’s Inflectra (infliximab-dyyb).

FDA: New Boxed Warnings for Opioids Used With Benzodiazepines

A boxed warning is the strongest type of FDA labeling Read More...

Combined use of opioids, often found in pain and cough medicines, and benzodiazepines, a class used for anxiety, insomnia and seizure control can lead to dangerous, even fatal slowed breathing (respiratory depression). To warn of this drug interaction, the FDA will require boxed warnings to inform of this risk when drugs from these two classes are combined. Common opioids include drugs like OxyContin and Vicodin, and benzodiazepines include Valium and Xanax. Healthcare provider should limit prescribing these classes together and warn patients of these dangerous effects, including interactions with alcohol and other central nervous system depressants.

Afluria Quadrivalent Approved in Time for 2016-2017 Flu Season

More than 200,000 people in the US are hospitalized each year due to influenza-related complications Read More...

Afluria Quadrivalent (influenza virus vaccine) has been FDA-approved and is now available in both the trivalent and quadrivalent formulation, just in time for the 2016-2017 influenza season. Afluria, from Seqirus, is an inactivated influenza vaccine used to immunization adults against influenza disease caused by influenza A and B viruses contained in the vaccine. Earlier this year, FDA also approved Seqirus’ Flucelvax Quadrivalent. The trivalent Afluria injection can be used in people 5 years of age and older. However, for adults 18 to 64 years of age, Afluria can be administered without a needle, using a needle-free injector.

Potential Zika Drug Treatment Already Exists on U.S. Market

Zika infection leads to newborns with undersized heads and underdeveloped brains Read More…

Studies have identified three possible drugs that could serve as treatments for the devastating effects of Zika virus. Researchers at Florida State University screened 6,000 different compounds that included already-approved drugs and clinical trial drug candidates. One drug -- niclosamide -- is  currently FDA-approved as a treatment for tapeworm, but seems to have antiviral properties that inhibit Zika from replicating. Two other compounds are still investigational; PHA-690509 which interferes with gene expression and Emricasan, awaiting FDA review. Zika is at epidemic levels in Puerto Rico and active in two Miami neighborhoods. More research is in progress to determine if these agents are effective and safe in pregnant women.

Mylan To Offer Generic Epipen: But Will It Now Be Affordable?

EpiPens are used to treat anaphylaxis, a severe, potentially fatal allergic reaction Read More...

After a busy week of criticism, Mylan has decided to offer a generic, lower cost version of EpiPen (epinephrine injection) in the U.S. EpiPen is a commonly prescribed emergency epinephrine treatment carried by kids and adults with life-threatening allergies to bees, peanuts, eggs, and other allergens. Most recently, Epipen has listed for close to $600 for two pens at the pharmacy. The generic version will have a list price of $300 for a two-pack. But with a quick expiration date and the need to have several injections at home, work or school, the cost of the medication can add up. Even with insurance, generic costs can be a burden for those with a high deductible.