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Zurzuvae received FDA approval


Zurzuvae received FDA approval   


Recently, the US Food and Drug Administration (FDA) approved Zurzuvae, an innovative oral medication that Biogen and Sage Therapeutics jointly developed to treat major depressive disorder (MDD) and postpartum depression. Millions of women suffering from these crippling diseases now have hope and treatment thanks to this ground-breaking drug. 


Understanding the Purpose of Zurzuvae  


Being the first oral medication particularly created to treat severe postpartum depression, Zurzuvae represents a significant advancement in the field of mental medicine. In addition to PPD, Zurzuvae focuses on MDD, commonly known as clinical depression, and offers a comprehensive strategy to help people who are coping with these mental health difficulties. 


Postpartum Depression's Effects  


The effects of PPD on the lives of affected women are extensive. After giving birth, the disease seriously impairs their capacity to resume regular functioning. It may harm the mother's relationship with her new baby and cause emotional upheaval, anxiety, and despair. The FDA's approval of Zurzuvae offers a glimmer of hope for easing the suffering experienced by women suffering from postpartum depression since it recognizes the seriousness of this issue. 


Zurzuvae's anticipated availability  


After receiving FDA approval, Zurzuvae is anticipated to go on sale in the fourth quarter of 2023. The US Drug Enforcement Administration is expected to schedule it as a prohibited substance within the next 90 days, though. When it becomes available, Zurzuvae is expected to revolutionize the field of mental health care.


FDA's Complete Response Letter: Insights  


During the review process, the FDA released a Complete Response Letter on Zurzuvae's treatment of adults with MDD.The agency stated that the application did not give enough proof of the drug's efficacy in treating MDD. To support its approval in this area, additional research is required.


Depression Illnesses Are Common  


In the US, depressive disorders, including MDD, are extremely common. According to estimates, at least one episode of major depressive disorder was experienced by 21 million adults nationwide in 2021. Additionally, one in seven women who give birth experience PPD. Zurzuvae's accessibility as an oral medicine offers fresh promise for more successful treatment of various mental health issues. 


Prior treatment options and standard PPD treatments

 

Intravenous injections were the primary method of treatment for postpartum depression before Zurzuvae was approved. Women will now have the option to take an oral pill thanks to the introduction of Zurzuvae, increasing treatment accessibility and convenience. Antidepressants and psychotherapy are frequently combined with the drug Zurzuvae to treat and control the symptoms of postpartum depression. 

 

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Zurzuvae received FDA approval