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FDA News Briefs for Wednesday, June 19, 2019

June 19, 2019

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


FDA Expands Approval of Keytruda as Second-Line Therapy for Metastatic SCLC

The FDA has granted accelerated approval of Keytruda (pembrolizumab; Merck Sharp & Dohme Corp.) for metastatic small cell lung cancer (SCLC) with disease progression during or after platinum-based chemotherapy and at least 1 other prior line of therapy. Keytruda has been previously approved for numerous other oncology indications. More Information.


FDA Expands Approval for Victoza

The FDA has approved a supplemental new drug application for Victoza (liraglutide; Novo Nordisk Inc.), a glucagon-like peptide-1 (GLP-1) receptor agonist for pediatric patients ≥ 10 years old with type 2 diabetes. The Victoza label carries a boxed warning regarding the potential risk of causing C-cell tumors in mice and rats; it is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2). More Information.  


DEA Designation for Sunosi

The FDA approved a new drug application for Sunosi (solriamfetol; Jazz Pharmaceuticals Inc.) in March 2019 to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. Sunosi is an oral dopamine and norepinephrine reuptake inhibitor (DNRI). The Drug Enforcement Administration (DEA) designated Sunosi as a Schedule IV controlled substance since it has abuse potential similar to phentermine. It will be commercially available in July 2019. More Information.