FDA — authorised 22 December 2000
- Marketing authorisation holder: NOVARTIS
- Status: approved
🇺🇸 Starlix in United States
FDA authorised Starlix on 22 December 2000
Marketing authorisations
FDA — authorised 9 September 2009
- Application: ANDA077461
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: NATEGLINIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 September 2009
- Application: ANDA077463
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: NATEGLINIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 March 2011
- Application: ANDA077462
- Marketing authorisation holder: WATSON LABS
- Local brand name: NATEGLINIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 December 2015
- Application: ANDA205055
- Marketing authorisation holder: ALVOGEN
- Local brand name: NATEGLINIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 July 2016
- Application: ANDA205248
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: NATEGLINIDE
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Starlix, a medication, for its labelled indication on 22 August 2024. The marketing authorisation was granted to ZYDUS PHARMS, the holder of the application number ANDA205248. This approval was made under the standard expedited pathway.
FDA — authorised 18 June 2018
- Application: ANDA205544
- Marketing authorisation holder: RISING
- Local brand name: NATEGLINIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 April 2019
- Application: ANDA206432
- Marketing authorisation holder: CADILA PHARMS LTD
- Local brand name: NATEGLINIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA077467
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: NATEGLINIDE
- Indication: TABLET — ORAL
- Status: approved
Starlix in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Starlix approved in United States?
Yes. FDA authorised it on 22 December 2000; FDA authorised it on 9 September 2009; FDA authorised it on 9 September 2009.
Who is the marketing authorisation holder for Starlix in United States?
NOVARTIS holds the US marketing authorisation.