FDA — authorised 28 February 2011
- Marketing authorisation holder: ASTRAZENECA PHARMS
- Status: approved
🇺🇸 Daliresp in United States
FDA authorised Daliresp on 28 February 2011
Marketing authorisations
FDA — authorised 18 December 2012
- Application: NDA022522
- Marketing authorisation holder: ASTRAZENECA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 13 July 2018
- Application: ANDA208257
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ROFLUMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 August 2018
- Application: ANDA208272
- Marketing authorisation holder: TORRENT
- Local brand name: ROFLUMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 October 2018
- Application: ANDA208236
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: ROFLUMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 November 2018
- Application: ANDA208213
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: ROFLUMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 March 2019
- Application: ANDA208180
- Marketing authorisation holder: MICRO LABS
- Local brand name: ROFLUMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 March 2020
- Application: ANDA208247
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: ROFLUMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 February 2022
- Application: ANDA208303
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ROFLUMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 May 2022
- Application: ANDA208299
- Marketing authorisation holder: PRINSTON INC
- Local brand name: ROFLUMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 September 2022
- Application: ANDA208256
- Marketing authorisation holder: MSN
- Local brand name: ROFLUMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 April 2023
- Application: ANDA213298
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ROFLUMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 April 2023
- Application: ANDA212490
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: ROFLUMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 December 2023
- Application: NDA217242
- Marketing authorisation holder: ARCUTIS
- Indication: Type 3 - New Dosage Form and Type 4 - New Combination
- Status: approved
FDA — authorised 9 July 2024
- Application: NDA215985
- Marketing authorisation holder: ARCUTIS
- Indication: Efficacy
- Status: approved
The FDA approved Daliresp, developed by ARCUTIS, for its approved indication on 2024-07-09. The application number for this approval is NDA215985. This approval was granted through the standard expedited pathway.
Daliresp in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Daliresp approved in United States?
Yes. FDA authorised it on 28 February 2011; FDA authorised it on 18 December 2012; FDA authorised it on 13 July 2018.
Who is the marketing authorisation holder for Daliresp in United States?
ASTRAZENECA PHARMS holds the US marketing authorisation.