The Food and Drug Administration (FDA) has posted a discontinuation notice for Requip (ropinirole HCl; GlaxoSmithKline) tablets and certain Requip XL (ropinirole HCl; GlaxoSmithKline) extended-release tablets.
Requip and Requip XL are non-ergot dopamine agonists indicated for the treatment of Parkinson’s disease.
The affected products include Requip 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg, and 5mg strength tablets in 100-count bottles, and Requip XL 2mg strength tablets in 30-count bottles. The anticipated final dates of availability to patients are as follows:
- Requip 0.25mg (NDC 0007-4890-20): April 2019
- Requip 0.5mg (NDC 0007-4891-20): May 2019
- Requip 1mg (NDC 0007-4892-20): January 2019
- Requip 2mg (NDC 0007-4893-20): January 2019
- Requip 3mg (NDC 0007-4895-20): April 2019
- Requip 4mg (NDC 0007-4896-20): May 2019
- Requip 5mg (NDC 0007-4894-20): March 2019
- Requip XL 2mg (NDC 0007-4885-13): March 2019
The discontinuation of these products was a business decision, according to the FDA notice. Requip XL is still available as 4mg, 6mg, 8mg, and 12mg extended-release tablets.
For more information call (908) 293-5330 or visit FDA.gov.