FDA Requires Additional Data for Seroquel XR Additional Drug Applications
The U.S. FDA (Food and Drug Administration) has solicited AstraZeneca, the producers from Seroquel XR (quetiapine fumarate), for extra data for its expanded discharge tablets for the treatment of MDD (Major Depressive Disorder) in grown-up patients.
The FDA's CRL (Complete Response Letter) was sent to AstraZeneca on 24th December. AstraZeneca says it is assessing the substance of the letter and the proposed marking updates. The organization says it will continue talks with the FDA and will "give a reaction to the office at the appropriate time".
SEROQUEL XR, a once-every day, broadened discharge plan of SEROQUEL (quetiapine fumarate), was endorsed in the United States in 2007 for the acute and support treatment of schizophrenia in grown-up patients and in October 2008 for the acute treatment of the depressive scenes related with bipolar disorder, the hyper and blended scenes related to bipolar I disorder, and the upkeep treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex.
AstraZeneca stresses that the CRL does not modify at all the present proposals for the treatment of patients taking Seroquel XR or Seroquel for officially affirmed signs of schizophrenia and bipolar disorder.
AstraZeneca, in an announcement to financial specialists, says it will provide details regarding progress when suitable.
References:
Nordqvist, C. (2008, December 26). "FDA Requires Additional Data For Seroquel XR Supplemental New Drug Application." Medical News Today. Retrieved from https://www.medicalnewstoday.com/articles/134131.php
The FDA's CRL (Complete Response Letter) was sent to AstraZeneca on 24th December. AstraZeneca says it is assessing the substance of the letter and the proposed marking updates. The organization says it will continue talks with the FDA and will "give a reaction to the office at the appropriate time".
SEROQUEL XR, a once-every day, broadened discharge plan of SEROQUEL (quetiapine fumarate), was endorsed in the United States in 2007 for the acute and support treatment of schizophrenia in grown-up patients and in October 2008 for the acute treatment of the depressive scenes related with bipolar disorder, the hyper and blended scenes related to bipolar I disorder, and the upkeep treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex.
AstraZeneca stresses that the CRL does not modify at all the present proposals for the treatment of patients taking Seroquel XR or Seroquel for officially affirmed signs of schizophrenia and bipolar disorder.
AstraZeneca, in an announcement to financial specialists, says it will provide details regarding progress when suitable.
References:
Nordqvist, C. (2008, December 26). "FDA Requires Additional Data For Seroquel XR Supplemental New Drug Application." Medical News Today. Retrieved from https://www.medicalnewstoday.com/articles/134131.php
Post a Comment for "FDA Requires Additional Data for Seroquel XR Additional Drug Applications"
Your Responds
Post a Comment