Markey, Hatch push for opioid warning

Boston Herald-17 hours ago

“Because of the confusing names and ingredients, many families may not know that they have just left the pharmacy with a bottle full of danger,” Markey said .

FDA to Veterinarians: Use Approved Mirtazapine Product

FDA to Veterinarians: Use Approved Mirtazapine Product American Veterinarian Compounded formulations, on the other hand, have not been reviewed by ... “As with many compoundedtransdermal drugs, the rate and degree of ...

VP of Sales for North Alabama Compounding Pharmacy Charged in Insurance Conspiracy

VP of Sales for North Alabama Compounding Pharmacy Charged in Insurance Conspiracy

Insurance News Net

"Global Compounding stole from insurance programs, including Medicare and TRICARE, by using a marketing scheme that increased the sales of ...

Athenex Gets FDA Compounding Policy Wrong, Amicus Says

Athenex Gets FDA Compounding Policy Wrong, Amicus Says Law360 Chiming in through an amicus brief Thursday, PharMEDium Services LLC said the FDA only allows for drugs to be compounded in bulk under section ..

Very High Importance! 'Stuff floating' in compounded drugs prompts FDA to appeal for more funding STAT

'Stuff floating' in compounded drugs prompts FDA to appeal for more funding STAT ASHINGTON — The Food and Drug Administration doesn't have enough funding or staff to properly regulate pharmaceutical compounders, a top ...

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Pharma push for Medicare donut hole change tangles opioid negotiations

A push by Big Pharma to claw back Medicare Part D donut hole money as part of the opioids package has hit against sharp Democratic opposition.  READ MORE

FDA Animal Drug Safety Communication: FDA Reminds Veterinarians of the Differences Between Approved and Compounded Formulas of Transdermal Mirtazapine for the Management of Weight Loss in Cats

In a Dear Veterinarian Letter issued today, the U.S. Food and Drug Administration reminded veterinarians of the differences between Mirataz (mirtazapine transdermal ointment), an animal drug that the FDA approved in May 2018 with demonstrated safety and effectiveness to manage undesired weight loss in cats, compared to the use of compounded formulations of transdermal mirtazapine, which some veterinarians started prescribing before there was an FDA-approved product available. FDA approval of this drug means that veterinarians have an approved mirtazapine product with known safety, efficacy, and quality to provide to their patients rather than relying on the only previously available products that are compounded from bulk drug substances that are unapproved animal drugs. Unlike FDA-approved Mirataz, compounded formulations of transdermal mirtazapine have not been reviewed by the FDA for safety or effectiveness and may vary in quality and potency. With many compounded transdermal drugs, the rate and degree of absorption are unknown and may vary to deliver too little or too much of the active ingredient, making treatment outcomes unpredictable. Manufactured for Kindred Biosciences Inc., Mirataz is a prescription animal drug that is intended to be applied topically on the inner surface of the cat’s ear once daily for 14 days. Mirataz must be prescribed by a licensed veterinarian because a trained professional is needed to correctly diagnose the cause of weight loss in cats and determine whether the drug is an appropriate treatment. Press Release

Essential! High Importance! Must Read!! Blindsided:At Least 68 People Are Nearly Blind After A Botched Drug Was Injected Into Their Eyeballs Their tragedies expose a shadowy US industry that sells drugs with little government oversight. by Stephanie M. Lee

https://www.buzzfeednews.com/article/stephaniemlee/guardian-pharmacy-compounding-lawsuits-cataracts