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Pulse Newsletter

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

Volume 1 | Issue 6
April 15, 2019

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

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Clinical Update

FDA approves new oral treatment for multiple sclerosis

Mavenclad® (cladribine) has been approved by the FDA to treat adults diagnosed with relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS). MS is a chronic, inflammatory condition in which the immune system mistakenly attacks the protective layer insulating nerve fibers, causing miscommunication between the brain and the rest of the body. The approval of Mavenclad® has expanded treatment options for those who have had an inadequate response to, or are unable to tolerate, an alternative drug used to treat MS. In a clinical trial of 1,326 patients with relapsing forms of MS, Mavenclad® was shown to have decreased the number of annual relapses per patient by 55-58% compared to placebo.

Safety First

Ata Int. Inc. issues voluntary nationwide recall of BLUEFUSION capsules, due to presence of undeclared ingredients

A consumer-level recall of BLUEFUSION capsules - a dietary supplement marketed for male enhancement and available without a prescription - has been initiated as a result of a recent FDA analysis, which found the product to contain undeclared active ingredients including sildenafil, tadalafil, and other prescription drugs commonly used to treat erectile dysfunction. Consequently, BLUEFUSION now falls under the category of unapproved drug, as the FDA was not made aware of all ingredients, therefore making it subject to recall. Consumers taking this medication should be aware that the newly identified ingredients have the potential to interact with nitrates, found in some prescription drugs, and may lead to dangerously low blood pressure levels if combined. As of the recall announcement date, March 21st, 2019, Ata Int. Inc. has not yet received any reports of adverse events in relation to this recall.

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From the Industry

FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic

In March, the FDA approved Spravato™ (esketamine) nasal spray, the first medication in the past 30 years with a new mechanism of action indicated for patients with treatment resistant depression. Esketamine is structurally related to Ketalar® (ketamine), which was approved by the FDA in 1970. This is the first FDA approval of esketamine for any indication. Because of the risk of adverse reactions and potential for abuse and misuse of the drug, it is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS). In the United States an estimated 17.3 million adults and 3.2 million adolescents aged 12 to 17 had at least one major depressive episode according to the latest National Survey on Drug Use and Health issued by the National Institute of Mental Health in 2017.

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FDA Approvals

Recent FDA Approvals

New Drug Approval: Zulresso™ (brexanolone)
Intravenous infusion for the treatment of postpartum depression (PPD) in adult women [3/19/2019 – Breakthrough TherapyPriority Review – SAGE THERAPEUTICS]

New Drug Approval: Sunosi™ (solriamfetol) (netarsudil/latanoprost)
Oral tablets for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea [3/20/2019 – JAZZ PHARMA IRELAND LTD]

New Drug Approval: Mayzent® (siponimod)
Oral tablets for the treatment of adults with relapsing forms of multiple sclerosis [3/26/19 – NOVARTIS PHARMS CORP]

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New Generics

New Generics Entering the Marketplace

TrophAmine® (premasol)
Indication: Nutrition support
Dosage Form/Strength: 6% Injection
Average Wholesale Price (AWP): Generic = $95 | Brand = $54

EryPed® (erythromycin ethylsuccinate)
Indication: Bacterial infection
Dosage Form/Strength: 400MG/5ML Suspension
Average Wholesale Price (AWP): Generic = $714 | Brand = $794