FDA News Briefs for Monday, June 24, 2019June 24, 2019
These Food and Drug Administration (FDA) developments came in last week:
FDA Approves Vyleesi for Hypoactive Sexual Desire Disorder in Premenopausal Women
The FDA has approved Vyleesi (bremelanotide; AMAG Pharmaceuticals) for the treatment of premenopausal women with acquired, generalized hypoactive desire disorder. This melanocortin receptor agonist is administered via subcutaneous injection at least 45 minutes before sexual activity. Patients should not administer more than 1 dose within 24 hours or exceed 8 doses per month. More Information.
FDA Expands Approval for Symdeko
The FDA has approved a supplemental new drug application for Symdeko (tezacaftor/ivacaftor; Vertex Pharmaceuticals Inc.). Symdeko is an oral combination tablet now indicated for the treatment of cystic fibrosis in patients aged 6 years and older with a homozygous F508del mutation or at least 1 mutation in the CFTR gene. Symdeko was previously approved for the same indication in patients aged 12 years and older. More Information.
Teleflex Medical Sheridan Endotracheal Tubes and Connectors Recalled
Teleflex Medical has issued a recall for multiple models of endotracheal tubes due to the risk of the Sheridan connector disconnecting from the breathing circuit. The FDA identified this as a Class I recall, as it may result in serious injuries or death. More Information.