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.

(Updated January 25, 2019)

The FDA has approved the following drug:
  • Ontruzant (trastuzumab-dttb) intravenous injection, a biosimilar to Herceptin (trastuzumab), to treat adjuvant breast cancer, metastatic breast cancer, and metastatic gastric cancer. Labeling includes a Boxed Warning regarding the risks of cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity. 
The FDA has approved the following new indication:
  • Cabometyx (cabozantinib) oral tablets to treat patients with advanced hepatocellular carcinoma previously treated with sorafenib. Cabometyx is also approved to treat advanced renal cell carcinoma.
The FDA has approved the following expanded indications:
  • Adacel (tetanus toxoid/reduced diphtheria toxoid/acellular pertussis vaccine, adsorbed [Tdap]) suspension for intramuscular injection to include repeat vaccination to help protect against tetanus, diphtheria, and pertussis. Adacel is the first and only Tdap vaccine in the US approved for a repeat dose in people 10 to 64 years of age, 8 years or more after the first vaccination.
  • Biltricide (praziquantel) oral tablets for patients 1 year and older (previously approved in patients 4 years and older) to treat schistosomiasis caused by all species of schistosoma, and of clonorchiasis and opisthorchiasis due to the liver flukes Clonorchis sinensis/Opisthorchis viverrini

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