Quetiapine XR Tablets ANDA filed (ANDA 209635) by ScieGen is fully reviewed by FDA and approved on November 29, 2017. <br></br>
From 2017 ScieGen is producing this product and distributed into the market. <br></br>
During this period we never received any complaints from the customers on any adverse events and side effects. ScieGen performed Bioequivalence studies at Synchron (a Contract Research organization, who performs the Bioavailability and Bioequivalence studies). <br></br>
Very recently FDA found some data integrity issues at Synchron. The issues observed at Synchron are not related to ScieGen’s product.
As precautionary measure FDA asked all ANDA holders who performed their respective BE studies at Synchron for last 10 years to repeat the Biostudies and submit the data with a agency with 12 months.
As part of this FDA decided to change status of all ANDA holders to “BX”, accordingly Sciegen’s product rating changed. FDA not asked us to recall the product.
FDA has stated in its press release and webpage that “FDA has been conducting an investigation of postmarket safety reports for marketing applications that relied on bioequivalence studies conducted by Synchron or Panexcell for approval. To date, the agency has not identified signals related to problems with the safety or quality of the approved drugs. FDA remains vigilant and if the agency finds safety issues, we will take action and provide the latest information as appropriate. Patients should not make changes to their treatment except in consultation with their health care professional.”<br></br>
ScieGen is planned to perform the BE studies, and will submit the data to agency by May’2022.<br></br>
Please visit the FDA webpage<br></br> <a href="https://www.fda.gov/drugs/drug-safety-and-availability/notification-pharmaceutical-companies-clinical-and-bioanalytical-studies-conducted-panexcell" target="_blank" rel="noopener">https://www.fda.gov/drugs/drug-safety-and-availability/notification-pharmaceutical-companies-clinical-and-bioanalytical-studies-conducted-panexcell</a>
ScieGen receives approval for Metformin ER tablets 500 mg and 1000 mg [ RLD , Glumetza ]
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ScieGen Metformin ER tablets 500 mg and 1000 mg complying to FDA requirements of NDMA content less 96 nanograms (0.0376 ppm).
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NDMA testing with a validated test method is a part of release and stability testing in Metformin ER tablets manufactured by ScieGen.
