FDA — authorised 16 April 1993
- Application: NDA020263
- Marketing authorisation holder: ABBVIE ENDOCRINE INC
- Local brand name: LUPRON DEPOT-PED KIT
- Indication: POWDER — INTRAMUSCULAR
- Status: approved
🇺🇸 Leuprolide Acetate in United States
FDA authorised Leuprolide Acetate on 16 April 1993
Marketing authorisations
FDA — authorised 4 August 1998
- Application: ANDA074728
- Marketing authorisation holder: SANDOZ
- Local brand name: LEUPROLIDE ACETATE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 3 March 2000
- Application: NDA021088
- Marketing authorisation holder: ORTHO MCNEIL JANSSEN
- Local brand name: VIADUR
- Indication: IMPLANT — IMPLANTATION
- Status: approved
FDA — authorised 25 October 2000
- Application: ANDA075471
- Marketing authorisation holder: MEITHEAL
- Local brand name: LEUPROLIDE ACETATE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 23 January 2002
- Application: NDA021343
- Marketing authorisation holder: TOLMAR
- Local brand name: ELIGARD KIT
- Indication: POWDER — SUBCUTANEOUS
- Status: approved
FDA — authorised 24 July 2002
- Application: NDA021379
- Marketing authorisation holder: TOLMAR
- Local brand name: ELIGARD KIT
- Indication: POWDER — SUBCUTANEOUS
- Status: approved
FDA — authorised 13 February 2003
- Application: NDA021488
- Marketing authorisation holder: TOLMAR
- Local brand name: ELIGARD KIT
- Indication: POWDER — SUBCUTANEOUS
- Status: approved
FDA — authorised 14 December 2004
- Application: NDA021731
- Marketing authorisation holder: TOLMAR
- Local brand name: ELIGARD KIT
- Indication: POWDER — SUBCUTANEOUS
- Status: approved
FDA — authorised 15 September 2005
- Application: NDA020011
- Marketing authorisation holder: ABBVIE ENDOCRINE INC
- Indication: Labeling
- Status: approved
FDA — authorised 9 March 2009
- Application: ANDA078885
- Marketing authorisation holder: SUN PHARM
- Local brand name: LEUPROLIDE ACETATE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 14 December 2012
- Application: NDA203696
- Marketing authorisation holder: ABBVIE ENDOCRINE
- Local brand name: LUPANETA PACK
- Indication: INJECTABLE, TABLET — INTRAMUSCULAR, ORAL
- Status: approved
FDA — authorised 1 May 2020
- Application: NDA213150
- Marketing authorisation holder: TOLMAR
- Local brand name: FENSOLVI KIT
- Indication: POWDER — SUBCUTANEOUS
- Status: approved
FDA — authorised 6 June 2022
- Application: ANDA212963
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: LEUPROLIDE ACETATE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 28 October 2022
- Application: ANDA215336
- Marketing authorisation holder: AMNEAL
- Local brand name: LEUPROLIDE ACETATE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 17 October 2024
- Application: ANDA217957
- Marketing authorisation holder: UBI
- Local brand name: LEUPROLIDE ACETATE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
The FDA approved Leuprolide Acetate for the treatment of patients with hormone-sensitive prostate cancer, precocious puberty, and endometriosis. The approval was granted to UBI, the marketing authorisation holder, following a standard expedited pathway. The approval date was 23 September 2025.
FDA — authorised 9 June 2025
- Application: ANDA217437
- Marketing authorisation holder: PH HEALTH
- Local brand name: LEUPROLIDE ACETATE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 13 November 2025
- Application: ANDA215826
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: LEUPROLIDE ACETATE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
Leuprolide Acetate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Leuprolide Acetate approved in United States?
Yes. FDA authorised it on 16 April 1993; FDA authorised it on 4 August 1998; FDA authorised it on 3 March 2000.
Who is the marketing authorisation holder for Leuprolide Acetate in United States?
ABBVIE ENDOCRINE INC holds the US marketing authorisation.