Received ANDA Approval for Diltiazem Hydrochloride Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg.
Received ANDA Approval for Pregabalin Extended-Release Tablets, 82.5 mg, 165 mg and 330 mg.
Received ANDA Approval for Pirfenidone Tablets, 267 mg and 801 mg.
Received ANDA Approval for Pirfenidone Capsules, 267 mg.
Received ANDA Approval for Lacosamide Tablets, USP 50 mg, 100 mg, 150 mg and 200 mg
Received ANDA Approval for Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 1000 mg
Received ANDA Approval for Valsartan Tablets USP, 40 mg, 80 mg, 160 mg, and 320 mg.
Quetiapine XR Tablets ANDA filed (ANDA 209635) by ScieGen is fully reviewed by FDA and approved on November 29, 2017.
From 2017 ScieGen is producing this product and distributed into the market.
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).
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.”
ScieGen is planned to perform the BE studies, and will submit the data to agency by May’2022.
Please visit the FDA webpage https://www.fda.gov/drugs/drug-safety-and-availability/notification-pharmaceutical-companies-clinical-and-bioanalytical-studies-conducted-panexcell
From 2017 ScieGen is producing this product and distributed into the market.
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).
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.”
ScieGen is planned to perform the BE studies, and will submit the data to agency by May’2022.
Please visit the FDA webpage https://www.fda.gov/drugs/drug-safety-and-availability/notification-pharmaceutical-companies-clinical-and-bioanalytical-studies-conducted-panexcell
Received ANDA Approval for Carbidopa and Levodopa Extended-Release Tablets, 25 mg/100 mg and 50 mg/200 mg.
Received original ANDA Approval for Levetiracetam Tablets, USP 750 mg and 1000 mg.
Received ANDA Approval for Carbidopa and Levodopa Tablets, USP 10mg/100 mg, 25 mg/100 mg and 25 mg/250 mg.
ScieGen receives approval for Metformin ER tablets 500 mg and 1000 mg [ RLD , Glumetza ]
ScieGen Metformin ER tablets 500 mg and 1000 mg complying to FDA requirements of NDMA content less 96 nanograms (0.0376 ppm).
NDMA testing with a validated test method is a part of release and stability testing in Metformin ER tablets manufactured by ScieGen.
ScieGen Metformin ER tablets 500 mg and 1000 mg complying to FDA requirements of NDMA content less 96 nanograms (0.0376 ppm).
NDMA testing with a validated test method is a part of release and stability testing in Metformin ER tablets manufactured by ScieGen.
Received ANDA Approval for Droxidopa Capsules, 100 mg, 200 mg, and 300 mg
Received ANDA Approval for Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg
Received ANDA Approval for Levetiracetam Extended-Release Tablets USP, 500 mg and 750 mg.
Received ANDA Tentative Approval for Pirfenidone Tablets, 267 mg and 801 mg
Received ANDA Tentative Approval for Pirfenidone Capsules, 267 mg
Received ANDA Approval for Ezetimibe Tablets, 10mg
Received ANDA Tentative Approval for Lacosamide Tablets, 50 mg, 100 mg, 150 mg, and 200 mg
Sciegen Metformin product – not part of Recall
Sciegen Pharmaceuticals Inc states that the Immediate release tablets Metformin Hydrochloride Tablets, USP 500 mg, 850 mg & 1000 mg manufactured by Sciegen Pharmaceuticals Inc are not part of recall regarding Metformin products.
Sciegen Metformin IR tablets complying to FDA requirements of NDMA content less 96 nanograms (0.0376 ppm).
Several batches manufactured by Sciegen are tested with a validated test method and the levels are found to ‘below detectable limit’.
This data has been submitted to FDA.
It should also be noted that FDA has stated in its press release on May 28th ‘The FDA recommends that health care professionals continue to prescribe metformin when clinically appropriate; FDA testing has not shown NDMA in immediate release (IR) metformin products (the most commonly prescribed type of metformin).’
https://www.fda.gov/news-events/press-announcements/fda-alerts-patients-and-health-care-professionals-nitrosamine-impurity-findings-certain-metformin
Sciegen Pharmaceuticals Inc states that the Immediate release tablets Metformin Hydrochloride Tablets, USP 500 mg, 850 mg & 1000 mg manufactured by Sciegen Pharmaceuticals Inc are not part of recall regarding Metformin products.
Sciegen Metformin IR tablets complying to FDA requirements of NDMA content less 96 nanograms (0.0376 ppm).
Several batches manufactured by Sciegen are tested with a validated test method and the levels are found to ‘below detectable limit’.
This data has been submitted to FDA.
It should also be noted that FDA has stated in its press release on May 28th ‘The FDA recommends that health care professionals continue to prescribe metformin when clinically appropriate; FDA testing has not shown NDMA in immediate release (IR) metformin products (the most commonly prescribed type of metformin).’
https://www.fda.gov/news-events/press-announcements/fda-alerts-patients-and-health-care-professionals-nitrosamine-impurity-findings-certain-metformin
Received ANDA Approval for Naproxen Tablets USP 250mg, 375mg and 500mg
Received ANDA Approval for Naproxen Sodium Tablets USP 275mg and 550mg
