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FDA News Briefs for Monday, May 13, 2019

May 13, 2019

These Food and Drug Administration (FDA) developments came in recently:

 

FDA Expands Approval of Cyramza

The FDA has granted expanded approval of Cyramza (ramucirumab; Eli Lilly) as single-agent therapy for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) of ≥ 400 ng/mL and have been treated with sorafenib. Cyramza was previously approved for treatment of certain patients with advanced gastric or gastro-esophageal junction adenocarcinoma, metastatic non-small cell lung cancer, and metastatic colorectal cancer. More Information.

 

Recall: Promacta Oral Suspension

Novartis has announced a voluntary recall of 3 lots of Promacta (eltrombopag) 12.5 mg for oral suspension due to a risk of potential peanut flour contamination that occurred at a third-party contract manufacturing site. More Information