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FDA News Briefs for Wednesday, June 05, 2019

June 5, 2019

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


FDA Expands Approval for Emgality

The FDA has approved a supplemental biologics license application for Emgality (galcanezumab-gnlm; Eli Lilly and Company). Emgality is a calcitonin-gene related peptide antagonist now indicated for the treatment of episodic cluster headache in adult patients. Emgality was previously approved for the preventive treatment of migraine in adult patients. More Information.


FDA Expands Approval for Zerbaxa

The FDA has granted expanded approval for Zerbaxa (ceftolozane and tazobactam; Merck Sharp & Dohme Corp.), a combination product now indicated for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in adult patients. Zerbaxa was previously approved for complicated intra-abdominal infections (used in combination with metronidazole) and complicated urinary tract infections. More Information.  


New Indication for OCS Lung System

The FDA has granted expanded approval for TransMedics’ Organ Care System (OCS), a portable normothermic organ perfusion, ventilation, and monitoring medical device. The OCS Lung System is now indicated for preservation of standard criteria donor lung pairs and for preservation of donor lung pairs initially deemed unacceptable for procurement and transplantation based on limitations of cold static preservation. It may be used with donors after circulatory death. This device also allows for ex-vivo assessment of donor lungs prior to transplantation. The OCS Lung System was previously approved for standard criteria lungs from donors after brain death only. More Information.