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Drug Update: September 2016 Issue 1

New Drug Approvals New Oral Formulation of Drug for Opioid-Induced Constipation This summer, the Food and Drug Administration (FDA) approved an oral formulation of Relistor® (methylnaltrexone bromide) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Methylnaltrexone was first approved in 2008 as a subcutaneous injection for the treatment of OIC […]

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Drug Update: August 2016 Issue 2

Specialty Update Advisory Panel to the FDA Votes in Favor of Approval of New Psoriasis Medication In July, an advisory panel to the U.S. Food and Drug Administration (FDA) voted in favor of a new monoclonal antibody, brodalumab, for the treatment of plaque psoriasis. The recommendation in favor of approval was contingent on the manufacturer, […]

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Drug Update: August 2016 Issue 1

New Drug Approvals U.S. Food and Drug Administration (FDA) Approves New Medication for Dry Eye Disease Last month, the FDA approved a first-in-class agent for the treatment of dry eye disease, Xiidra® 5% (lifitegrast ophthalmic solution). Xiidra is a twice-daily eye drop solution indicated for the treatment of signs and symptoms of dry eye disease in […]

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Drug Update: July 2016 Issue 2

FDA Drug Review News Advisory Panel to the FDA Votes in Favor of Approval of Two Combination Diabetes Drugs An advisory panel to the U.S. Food and Drug Administration (FDA) has voted in favor of approval of two new fixed-dose combination diabetes drug, iDegLira® and iGlarLixi®, for the treatment of type 2 diabetes in adults. […]

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Drug Update: July 2016 Issue 1

New Drug Approvals U.S. Food and Drug Administration (FDA) Approves New Biologic Drug for Multiple Sclerosis At the end of May, the FDA approved Zinbryta® (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis. Due to the potential for serious side effects, Zinbryta is reserved for patients who have had an inadequate […]

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Drug Update: June 2016 Issue 2

FDA Drug Review News FDA Expected to Vote on New Hepatitis C Drug This Month A New Drug Application (NDA) was submitted to the U.S. Food & Drug Administration (FDA) last fall for a novel combination hepatitis C medication manufactured by Gilead. The product, sofosbuvir/velpatasvir, is currently undergoing FDA review for the treatment of all […]

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Drug Update: June 2016 Issue 1

New Drug Approvals U.S. Food and Drug Administration (FDA) Approves First Drug to Treat Parkinson’s Related Psychosis At the end of April, the FDA approved Nuplazid® (pimavanserin) for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. Nuplazid is the first and only medication approved by the FDA for this indication. It is […]

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Drug Update: May 2016 Issue 2

FDA Drug Review News Advisory Panel to the FDA Recommends Prescription Acne Medication be Available Over-the-Counter In mid-April, an advisory panel to the U.S. Food and Drug Administration (FDA) voted 16 to 0 that the prescription topical acne agent adapalene gel 0.1% (Differin®) was safe for over-the-counter (OTC) use. However questions persist on the labeling […]