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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 1 | Issue 2
February 15, 2019

Chief Author: Kevin Lavery, PharmD
Editor: Dana Ranallo, PharmD

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Clinical Update

Nearly half of all Americans have cardiovascular disease, according to AHA

A new report released by the American Heart Association (AHA) found that 48% of all adults in the U.S. have some type of cardiovascular disease (CVD). The AHA largely attributes this year’s increased prevalence of CVD to recent changes in the way high blood pressure is defined. The cutoff for high blood pressure is now defined as 130/80 mmHg verus 140/90 mmHg previously. This release shortly follows a related report by the AHA that called out CVD as America’s costliest disease. According to their estimates, total CVD costs are expected to cost America $1.1 trillion by 2035, effectively doubling costs of $555 billion incurred in 2016.

Safety First

FDA issues Class 1 recall on strips used to monitor blood thinner warfarin

The FDA has issued the recall on Roche’s CoaguChek XS PT® Test Strips that are used to monitor patient response to warfarin, a blood thinner prescribed to prevent and treat blood clots. The FDA warns the strips may provide inaccurate test results that could result in the prescribing of insufficient warfarin doses, which may increase the risk for dangerous blood clots. Terrific Care LLC, the company identified as selling the affected batches, has sent an Urgent Notification letter to customers asking them to contact Roche Diagnostics to obtain new batches of strips and to contact their doctor while waiting for replacement strips.

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From the Industry

Innovation in respiratory disease management continues

The FDA has granted approval to Teva Pharmaceutical Industries’ ProAir® Digihaler™ for the management of asthma and COPD. The device is the first and only digital inhaler with built-in sensors that detect when the inhaler is used and measure inhalation flow. The inhaler is linked to a mobile application that provides data to patients via Bluetooth technology so they can review and share it with their health care providers. Teva says the inhaler will be piloted in limited areas in 2019 with nationwide distribution of the device planned for 2020.

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FDA Approvals

Recent FDA Approvals

3 new dosage forms approved:

Tosymra™ (sumatriptan)
Nasal spray for the treatment of acute migraine [1/25/19 – DR REDDYS LABS]

Evekeo ODT™ (amphetamine sulfate)
Orally disintegrating tablets for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in patients 6 to 17 years old [1/30/19 – ARBOR PHARMS]

Gloperba™ (colchicine)
Oral solution for the prevention of gout flares in adults [1/30/19 – ROMEG THERAPEUTICS]

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New Generics

New Generics Entering the Marketplace

toremifene (Fareston®)
Indication: Breast Cancer
Dosage Form/Strength: 60MG tablet
Average Wholesale Price (AWP): Generic = $1,375/30 day supply (DS) | Brand = $1,529/30 day supply (DS)

sirolimus (Rapamune®)
Indication: Organ Rejection
Dosage Form/Strength: 1MG/ML solution
Average Wholesale Price (AWP): Generic = $2,100/30 day supply (DS) | Brand = $2,105/30 day supply (DS)