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Pulse Newsletter

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

Volume 1 | Issue 13
August 1, 2019

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

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Clinical Update

FDA and CDC continue joint effort to protect consumers from Cyclospora infections

In June 2019, the U.S. Food and Drug Administration (FDA) continued their efforts to protect consumers from Cyclospora illness by hosting a scientific workshop in collaboration with the Centers for Disease Control and Prevention (CDC), academic leaders, and industry experts to discuss gaps in detection methods and plans that will help keep the Cyclospora parasite out of food. Cyclosporiasis is an intestinal infection commonly characterized by diarrhea and nausea that is generally acquired following ingestion of food contaminated with Cyclospora, such as fresh produce or contaminated water. The CDC recommends all retailers and consumers follow safe food handling procedures to prevent these infections, including thorough hand washing and careful preparation before consumption. In 2018 alone, there were 2,299 cases of domestically acquired cyclosporiasis reported in 33 states resulting in 160 hospitalizations. In an effort to combat the growing public health burden of Cyclospora illness, the FDA created a multidisciplinary coalition known as the Cyclospora cayetanensis Task Force, which has worked to prevent infection through strategies such as development of new detection tools, web-based reporting and new surveillance techniques, including produce and water sampling. Improvement of detection and reporting tools has allowed the FDA to more efficiently track sources of contamination and swiftly eliminate them from the market, preventing additional illnesses.

Safety First

Voluntary recall of multiple ophthalmic products by Altaire Pharmaceuticals, Inc.

On July 3, 2019, Altaire Pharmaceuticals, Inc. announced a precautionary voluntary recall of multiple eye ointments due to management concerns surrounding Quality Assurance measures and potential non-sterility of the products. Commonly used products included in the recall include, but are not limited to antibiotics such as NEO-POLY-DEX (neomycin/polymixin B/dexamethasone) ointment and bacitracin ointment. Altaire Pharmaceuticals, Inc. has requested their distributor, Perrigo Company PLC, returns all affected lots and notifies their customers. The FDA reminds consumers that adverse reactions or quality problems experienced with the use of these products should be reported to the FDA MedWatch Adverse Event Reporting program. To date, Altaire has received no reports of adverse events for the recalled products.

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From the Industry

HIV eliminated in mice for the first time

According to a new study published in Nature Communications, a team of scientists from Temple University and the University of Nebraska Medical Center were able to eliminate the HIV virus from a subset of infected mice for the first time. To accomplish this feat, researchers utilized a combination of slow release anti-retroviral therapy, also known as LASER ART, and a gene-editing technology, known as CRISPR. Current HIV treatment involves lifelong medication known as antiretroviral therapy (ART), which suppresses viral replication but does not eliminate the virus from the body. The author of the study noted that more information needs to be gathered surrounding the potential toxicity of gene-modifying therapy and its implementation in humans. According to the most recent data available from the World Health Organization (WHO), it is estimated that nearly 37.9 million people were living with HIV /AIDS worldwide as of 2018.

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FDA Approvals

Recent FDA Approvals

Novel Drug Approval: Xpovio™ (selinexor)
Oral tablet for the treatment cancer that affects white blood cells, known as multiple myeloma [7/3/2019 – Fast Track; Orphan DrugPriority Review – KARYOPHARM THERAPEUTICS INC]

New Formulation: Katerzia™ (amlodipine benzoate)
Oral suspension for the treatment of high blood pressure and coronary artery disease (CAD) [7/8/2019 – SILVERGATE PHARMS]

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New Generics

New Generics Entering the Marketplace

Zantac® (ranitidine)
Indication: Ulcers
Dosage Form/Strength: 25MG/ML Injection
Average Wholesale Price (AWP): Generic = 25MG/ML ($644) | Brand = 25MG/ML ($716)

Uloric® (febuxostat)
Indication: Gout
Dosage Form/Strength: 40MG, 80MG Tablet
Average Wholesale Price (AWP): Generic = 40MG ($356) | Brand = 40MG ($396); Generic =80MG ($356) | Brand = 80MG ($396)