BLA 103691

SMITH AND NEPHEW

FDA Drug Application

Application #103691

Documents

• Letter: 2005-05-20
• Letter: 2012-05-03
• Label: 2004-03-11
• Label: 2009-10-02
• Other Important Information from FDA: 2004-03-11
• Letter: 2004-03-11
• Letter: 2008-10-23
• Label: 2005-05-20
• Label: 2011-03-21
• Review: 2004-03-11
• Review: 2012-02-14
• Label: 2018-11-30
• Medication Guide: 2018-11-30
• Letter: 2018-12-19
• Letter: 2019-08-27
• Label: 2019-08-27
• Medication Guide: 2019-08-27

Application Sponsors

BLA 103691

SMITH AND NEPHEW

Marketing Status

• Prescription: 001

Application Products

001

GEL; TOPICAL

100UG/G

0

REGRANEX

BECAPLERMIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1997-12-16	UNKNOWN
EFFICACY; Efficacy	SUPPL	5015	AP	2005-05-13	STANDARD
LABELING; Labeling	SUPPL	5074	AP	2008-10-16	STANDARD
LABELING; Labeling	SUPPL	5086	AP	2010-04-09	STANDARD
LABELING; Labeling	SUPPL	5087	AP	2010-04-28	STANDARD
LABELING; Labeling	SUPPL	5095	AP	2011-03-11	STANDARD
LABELING; Labeling	SUPPL	5109	AP	2012-04-30	STANDARD
EFFICACY; Efficacy	SUPPL	5134	AP	2018-11-28	STANDARD
LABELING; Labeling	SUPPL	5138	AP	2019-08-26	STANDARD

Submissions Property Types

SUPPL	5087	Null	7
SUPPL	5109	Null	7
SUPPL	5134	Null	7
SUPPL	5138	Null	15

CDER Filings

SMITH AND NEPHEW

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 103691
            [companyName] => SMITH AND NEPHEW
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/103691s5138lbl.pdf#page=8"]
            [products] => [{"drugName":"REGRANEX","activeIngredients":"BECAPLERMIN","strength":"100UG\/G","dosageForm":"GEL; TOPICAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/26\/2019","submission":"SUPPL-5138","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103691s5138lbl.pdf\"}]","notes":""},{"actionDate":"11\/28\/2018","submission":"SUPPL-5134","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103691s5134lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2011","submission":"SUPPL-5095","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/103691s5095lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2008","submission":"SUPPL-5074","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/103691s5074lbl.pdf\"}]","notes":""},{"actionDate":"05\/13\/2005","submission":"SUPPL-5015","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/103691s5015lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/1997","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1997\\\/becaomj121697-lab.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/16\/1997","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1997\\\/becaomj121697-lab.pdf\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/1997\\\/becaomj121697L.htm\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/web.archive.org\\\/web\\\/20170113111514\\\/https:\\\/\\\/www.fda.gov\\\/Drugs\\\/DevelopmentApprovalProcess\\\/HowDrugsareDevelopedandApproved\\\/ApprovalApplications\\\/TherapeuticBiologicApplications\\\/ucm080740.htm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"08\/26\/2019","submission":"SUPPL-5138","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103691s5138lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/103691Orig1s5138ltr.pdf\"}]","notes":">"},{"actionDate":"11\/28\/2018","submission":"SUPPL-5134","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103691s5134lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/103691Orig1s5134ltr.pdf\"}]","notes":">"},{"actionDate":"04\/30\/2012","submission":"SUPPL-5109","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/103691s5109ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"03\/11\/2011","submission":"SUPPL-5095","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/103691s5095lbl.pdf\"}]","notes":">"},{"actionDate":"04\/28\/2010","submission":"SUPPL-5087","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/09\/2010","submission":"SUPPL-5086","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/16\/2008","submission":"SUPPL-5074","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/103691s5074lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2008\\\/103691s5074ltr.pdf\"}]","notes":">"},{"actionDate":"05\/13\/2005","submission":"SUPPL-5015","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/103691s5015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2005\\\/103691s5015ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2005\\\/103691Orig1s5015Approv.pdf\"}]","notes":">"}]
            [actionDate] => 2019-08-26
        )

)