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Drug Update: May 2016 Issue 1

New Drug Approvals U.S. Food and Drug Administration (FDA) Approves New Drug for Leukemia Last month, the FDA approved Venclexta® (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy and have a chromosomal abnormality known as the 17p deletion. Venclexta is an oral tablet indicated […]

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Drug Update: April 2016 Issue 2

FDA Drug Review News Advisory Panel to the U.S. Food and Drug Administration (FDA) Reviews Drug for Parkinson’s Related Psychosis An advisory panel to the U.S. FDA voted 12 to 2 that the benefits of pimavanserin (Nuplazid®) outweigh the risks for patients with psychosis associated with Parkinson’s disease. However, the advisory panel did not vote […]

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Drug Update: April 2016 Issue 1

FDA Drug Review News FDA Approves Zurampic® (lesinurad) for Adjunctive Treatment of Gout In December 2015, Zurampic was FDA-approved to be used in combination with a xanthine oxidase inhibitor for the treatment of hyperuricemia in patients with gout who had not achieved target serum uric acid levels. Zurampic reduces serum uric acid levels by inhibiting […]

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Drug Update: March 2016 Issue 2

FDA Drug Review News U.S. Food and Drug Administration Expands Indication for Cancer Drug Imbruvica® In March 2016, the U.S. Food and Drug Administration (FDA) approved Imbruvica® (ibrutinib) as first-line treatment for patients with chronic lymphocytic leukemia (CLL) regardless of treatment history (treatment-naïve or previously-treated). This approval marks the 5th treatment indication for Imbruvica, and […]

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Drug Update: March 2016 Issue 1

FDA Approves Briviact® (brivaracetam) for Treatment of Partial Onset Seizures The US Food and Drug Administration (FDA) approved Briviact (brivaracetam) on February 19, 2016. It is a selective, high-affinity synaptic vesicle protein 2A ligand and an analogue of the antiepileptic drug levetiracetam. Briviact is indicated as add-on therapy in the treatment of partial onset seizures […]

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Drug Update: February 2016 Issue 2

FDA Drug Review News U.S. Food and Drug Administration Approves Concentrated Insulin Pen Last month, the FDA approved Humulin® R U-500 KwikPen® (insulin human injection), the first prefilled pen device that contains 500 units of insulin per milliliter. The insulin contained within this KwikPen, Humulin R U-500, is five-times more concentrated than standard U-100 insulin […]

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Drug Update: February 2016 Issue 1

FDA Drug Review News U.S. Food and Drug Administration Grants Priority Review to New Leukemia Drug In January of this year, the U.S. Food and Drug Administration (FDA) granted Priority Review to the New Drug Application (NDA) for venetoclax. Venetoclax is being reviewed for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who […]

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Drug Update: January 2016

FDA Approves Zurampic® (lesinurad) Tablets for Treatment of Hyperuricemia-Associated with Gout The U.S. Food and Drug Administration (FDA) has approved Zurampic for the treatment of high uric acid levels associated with gout in patients that have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone. Zurampic should be used in combination with […]