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Published byDerek Whitehead Modified over 6 years ago
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Patrick Kurunwune, PharmD Candidate Cone Health Family Medicine
News You Can Use… Patrick Kurunwune, PharmD Candidate Alyson Leonard, PharmD Pete Koval, PharmD Cone Health Family Medicine April, 2017
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FDA Approval Qtern® (dapagliflozin and saxagliptin)
The first FDA approved DPP-4 inhibitor and SGLT-2 inhibitor combination Formulation /Dosing Tablet: 10 mg dapagliflozin/5 mg saxagliptin FDA approved 2/28/2017 however, no availability date at this time
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FDA Approval Emflaza® (deflazacourt) Formulation/Dosing Pricing
Corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older Formulation/Dosing Tablets: 6mg, 18mg, 30mg, and 36mg Oral Suspension: mg/mL Pricing $89,000
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FDA Approval Dupixent® (dupilumab) Formulation/ Dosing Pricing
injection to treat adults with moderate-to- severe eczema Class: Interleukin-4 Receptor Antagonist; Monoclonal Antibody Formulation/ Dosing Injection: 300 mg/2 mL Pricing $37,000
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FDA Approval Ocrevus® (ocrelizumab) Formulation/Dosing Pricing
First drug approved by the FDA for primary progressive multiple sclerosis (PPMS) Class: Monoclonal Antibody Formulation/Dosing Injection: 300 mg/10 mL (30 mg/mL) in a single-dose vial Pricing $65,000 per year (2 shots per year)
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Viberzi: FDA Drug Safety
Viberzi® (eluxadoline) For the treatment of IBS FDA Drug Safety Alert Do NOT prescribe Viberzi (eluxadoline) in patients who do not have a gallbladder FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death
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Basaglar® – Insulin Glargine
Biosimilar Insulin Glargine AKA “Lantus®” Now available in the market place! Dose conversion – Direct 1:1 Consider when insurance dictates At this time insurance coverage is in transition Expect plans to consider this as price appears to be competitive $330 vs $ 380 (Lantus Solostar) for 5 pens Pricing from GoodRx.com - Accessed 4/3/2017
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Biosimilar Coming Soon!
Currently about 30 “biologic specialty drugs” pending approvals at the FDA 73 biologic patent expirations by 2021 Biologic “biosimilars” serve as competing brands Biosimilar Naming (FDA 1/17) Named by their reference biologics’ generic names plus a four-letter suffix, such as “filgrastim-sndz” for Sandoz’s biosimilar
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