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Please can anybody tell me the BCS classification of Darifenacin
HBr...antimuscarinic drug
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The following message was posted to: PharmPK
In the US, darfenacin was approved as an extended release formulation;
therefore, a BCS determination was not made by the sponsor/FDA.
Carol Collins MD
Senior Research Scientist
University of Washington
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The following message was posted to: PharmPK
Dear Mr.Deveshbhatt,
FDA approved both 7.5mg and 15mg Darifenacin Hydrobromide only as
"Extended Release Tablets" with Reference Listed Drug application number
21513. Hence, Biopharmaceutics classification was not made by the
Innovator Novartis as well as by the FDA.
Kindly see the below link for your reference:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm081317.htm
http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=021513&TABLE1=OB_Rx
Regards,
Dr.S.Gunasakaran,MBBS,MD
Medical Affairs
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The following message was posted to: PharmPK
I don't do BCS since that has regulatory significance and as pointed
out by others since darifenacin is an extended release product does
not qualify. However, Prof. Tudor Oprea and I have classified 834
drugs in terms of BDDCS, which we will publish soon, and we classify
darifenacin HBr as a Class 1 BDDCS drug.
Leslie Z. Benet, Ph.D.
Professor
Department of Bioengineering & Therapeutic Sciences
Schools of Pharmacy & Medicine
University of California San Francisco
533 Parnassus Avenue, Room U-68
San Francisco, CA 94143-0912
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