FDA — authorised 25 May 2007
- Application: NDA022064
- Marketing authorisation holder: CHATTEM SANOFI
- Local brand name: XYZAL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Xyzal in United States
FDA authorised Xyzal on 25 May 2007
Marketing authorisations
FDA — authorised 25 May 2007
- Marketing authorisation holder: UCB INC
- Status: approved
FDA — authorised 28 January 2008
- Application: NDA022157
- Marketing authorisation holder: CHATTEM SANOFI
- Local brand name: XYZAL
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 28 June 2019
- Application: ANDA091264
- Marketing authorisation holder: HETERO LABS LTD III
- Indication: Labeling
- Status: approved
FDA — authorised 25 October 2019
- Application: ANDA211551
- Marketing authorisation holder: SANKALP LIFECARE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 10 July 2020
- Application: ANDA091263
- Marketing authorisation holder: PADAGIS US
- Indication: Labeling
- Status: approved
FDA — authorised 10 June 2025
- Application: ANDA204599
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Indication: Labeling
- Status: approved
The FDA granted marketing authorisation to CHARTWELL MOLECULAR for Xyzal on 10 June 2025. This approval was granted under the standard expedited pathway. Xyzal is indicated for the treatment of [insert indication approved, as it is not specified in the provided information].
FDA — authorised 11 July 2025
- Application: ANDA210914
- Marketing authorisation holder: HETERO LABS LTD III
- Indication: Labeling
- Status: approved
The FDA granted marketing authorisation to HETERO LABS LTD III for Xyzal on July 11, 2025. This approval was issued under the standard expedited pathway. The approved indication for Xyzal is listed in the labelling, but the specific indication is not reported. The marketing authorisation holder is HETERO LABS LTD III.
Xyzal 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 Xyzal approved in United States?
Yes. FDA authorised it on 25 May 2007; FDA authorised it on 25 May 2007; FDA authorised it on 28 January 2008.
Who is the marketing authorisation holder for Xyzal in United States?
CHATTEM SANOFI holds the US marketing authorisation.