FDA — authorised 10 December 2004
- Application: NDA020333
- Marketing authorisation holder: TAKEDA PHARMS USA
- Indication: Labeling
- Status: approved
🇺🇸 Agrylin in United States
FDA authorised Agrylin on 10 December 2004
Marketing authorisations
FDA — authorised 31 August 2010
- Application: ANDA076811
- Marketing authorisation holder: NOVITIUM PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 13 November 2012
- Application: ANDA076683
- Marketing authorisation holder: CHARTWELL RX
- Indication: Labeling
- Status: approved
FDA — authorised 16 August 2024
- Application: ANDA209151
- Marketing authorisation holder: TORRENT
- Indication: Labeling
- Status: approved
The FDA approved Agrylin, a medication, for labeling indication on August 16, 2024. The marketing authorization was granted to TORRENT, the marketing authorization holder. The approval was made under the standard expedited pathway.
Agrylin 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 Agrylin approved in United States?
Yes. FDA authorised it on 10 December 2004; FDA authorised it on 31 August 2010; FDA authorised it on 13 November 2012.
Who is the marketing authorisation holder for Agrylin in United States?
TAKEDA PHARMS USA holds the US marketing authorisation.