Drug News

Stay up-to-date on the latest drug news. Learn about new drug approvals, labeling changes, expanded indications, recalls, and approvals of generic formulations. These drug news updates are compiled from the latest information from Facts & Comparisons® and the U.S. Food and Drug Administration.

DRUG NEWS
(Updated September 11, 2019)

The FDA has approved the following drug:
  • Nitisinone oral capsules, a generic of Orfadin, to treat adult and pediatric patients with hereditary tyrosinemia type 1 in combination with dietary restriction of tyrosine and phenylalanine.
The FDA has approved the following new indication:
  • Ofev (nintedanib) oral capsules to slow the decrease in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease. It is the first FDA-approved treatment for this condition. Ofev is also indicated to treat idiopathic pulmonary fibrosis.
The FDA has approved the following expanded indications:
  • Aubagio (teriflunomide) oral tablets to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. Aubagio was previously approved to treat relapsing forms of MS. Major risks include hepatotoxicity and embryofetal toxicity.
  • Extavia (interferon beta-1b) subcutaneous injection to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. Extavia was previously approved to treat relapsing forms of MS, to reduce the frequency of clinical aggravations.
The FDA has approved the following Boxed Warning:
  • Zolpimist (zolpidem tartrate) oral spray regarding the risk of complex sleep behaviors (eg, sleepwalking, sleep-driving). Zolpimist is indicated to treat short-term insomnia with sleep initiation difficulties. 

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