Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125390
Company: AEGERION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYALEPT METRELEPTIN 11.3MG INJECTABLE;INJECTION Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/24/2014 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125390Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125390Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125390Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/11/2017 SUPPL-12 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125390Orig1s012ltr.pdf
09/22/2015 SUPPL-10 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125390Orig1s010ltr.pdf
08/27/2015 SUPPL-6 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125390Orig1s006ltr.pdf
06/30/2014 SUPPL-4 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125390Orig1s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/22/2015 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s010lbl.pdf
08/27/2015 SUPPL-6 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s006lbl.pdf
08/27/2015 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s006lbl.pdf
08/27/2015 SUPPL-6 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s006lbl.pdf
08/27/2015 SUPPL-6 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s006lbl.pdf
06/30/2014 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s004lbl.pdf
02/24/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125390s000lbl.pdf

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