Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 125290
Company: NOVARTIS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EXTAVIA INTERFERON BETA-1B 0.0625MG INJECTABLE; SUBCUTANEOUS Prescription None TBD 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
08/14/2009 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125290s0000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125290s0000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125290_extavia_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/0125290s000sumr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/02/2020 SUPPL-70 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125290s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125290Orig1s070ltr.pdf
08/16/2019 SUPPL-67 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125290s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125290Orig1s067ltr.pdf
12/11/2018 SUPPL-66 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125290s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125290Orig1s066ltr.pdf
12/22/2015 SUPPL-63 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125290s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125290Orig1s063ltr.pdf
05/12/2016 SUPPL-62 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125290s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125290Orig1s062ltr.pdf
03/18/2012 SUPPL-33 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125290s0033ltr.pdf
06/22/2011 SUPPL-30 Supplement

Label is not available on this site.

12/22/2014 SUPPL-29 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125290Orig1s029ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/02/2020 SUPPL-70 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125290s070lbl.pdf
08/16/2019 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125290s067lbl.pdf
08/16/2019 SUPPL-67 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125290s067lbl.pdf
12/11/2018 SUPPL-66 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125290s066lbl.pdf
05/12/2016 SUPPL-62 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125290s062lbl.pdf
05/12/2016 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125290s062lbl.pdf
12/22/2015 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125290s063lbl.pdf
08/14/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125290s0000lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English