FDA — authorised 13 November 2001
- Marketing authorisation holder: NOVARTIS
- Status: approved
🇺🇸 Focalin in United States
FDA authorised Focalin on 13 November 2001
Marketing authorisations
FDA — authorised 25 April 2007
- Application: NDA021278
- Marketing authorisation holder: SANDOZ
- Indication: Labeling
- Status: approved
FDA — authorised 30 June 2015
- Application: ANDA078992
- Marketing authorisation holder: PLATINUM
- Indication: Labeling
- Status: approved
FDA — authorised 29 November 2019
- Application: ANDA201231
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Indication: Labeling
- Status: approved
FDA — authorised 9 September 2024
- Application: ANDA204534
- Marketing authorisation holder: NOVEL LABS INC
- Indication: Labeling
- Status: approved
Novel Labs Inc obtained marketing authorisation for Focalin in the United States on 2024-09-09. The approval was granted under application number ANDA204534. Focalin is indicated for use in the labelling provided by the manufacturer.
FDA — authorised 10 September 2024
- Application: ANDA206931
- Marketing authorisation holder: ABHAI LLC
- Indication: Labeling
- Status: approved
The FDA approved Focalin, a medication, for its labelled indication on 10 September 2024. The marketing authorisation holder is ABHAI LLC. This approval was granted under the standard expedited pathway.
Focalin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Focalin approved in United States?
Yes. FDA authorised it on 13 November 2001; FDA authorised it on 25 April 2007; FDA authorised it on 30 June 2015.
Who is the marketing authorisation holder for Focalin in United States?
NOVARTIS holds the US marketing authorisation.