3
Oct 22
Received ANDA Approval for Diltiazem Hydrochloride Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg.
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14
Sep 22
Received ANDA Approval for Pregabalin Extended-Release Tablets, 82.5 mg, 165 mg and 330 mg.
Read More
1
Aug 22
Received ANDA Approval for Pirfenidone Tablets, 267 mg and 801 mg.
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1
Aug 22
Received ANDA Approval for Pirfenidone Capsules, 267 mg.
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17
Mar 22
Received ANDA Approval for Lacosamide Tablets, USP 50 mg, 100 mg, 150 mg and 200 mg
Read More
22
Feb 22
Received ANDA Approval for Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 1000 mg
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27
Oct 21
Received ANDA Approval for Valsartan Tablets USP, 40 mg, 80 mg, 160 mg, and 320 mg.
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27
Oct 21
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
Read More
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
5
Oct 21
Received ANDA Approval for Carbidopa and Levodopa Extended-Release Tablets, 25 mg/100 mg and 50 mg/200 mg.
Read More
11
Jun 21
Received original ANDA Approval for Levetiracetam Tablets, USP 750 mg and 1000 mg.
Read More
News / Announcements
3
Oct 22
Received ANDA Approval for Diltiazem Hydrochloride Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg.
Read More
14
Sep 22
Received ANDA Approval for Pregabalin Extended-Release Tablets, 82.5 mg, 165 mg and 330 mg.
Read More
1
Aug 22
Received ANDA Approval for Pirfenidone Tablets, 267 mg and 801 mg.
Read More
1
Aug 22
Received ANDA Approval for Pirfenidone Capsules, 267 mg.
Read More
17
Mar 22
Received ANDA Approval for Lacosamide Tablets, USP 50 mg, 100 mg, 150 mg and 200 mg
Read More
22
Feb 22
Received ANDA Approval for Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 1000 mg
Read More
27
Oct 21
Received ANDA Approval for Valsartan Tablets USP, 40 mg, 80 mg, 160 mg, and 320 mg.
Read More
27
Oct 21
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
Read More
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
5
Oct 21
Received ANDA Approval for Carbidopa and Levodopa Extended-Release Tablets, 25 mg/100 mg and 50 mg/200 mg.
Read More
11
Jun 21
Received original ANDA Approval for Levetiracetam Tablets, USP 750 mg and 1000 mg.
Read More
