Capsaicin patch license extension application withdrawn
21st March 2012
Astellas Pharma has withdrawn its application to the European Medicines Agency (EMA) for a license extension for Qutenza® (capsaicin 8% transdermal patch). The application was to extend the marketing authorization for Qutenza® to all adult patients with exclusion of patients with pain caused by diabetes.
The withdrawal was based on the Committee for Medicinal Products for Human Use (CHMP)'s view that the data provided would not allow the committee to conclude on a positive benefit-risk balance.
Qutenza® continues to be authorized for the treatment of peripheral neuropathic pain (PNP) in non-diabetic adults either alone or in combination with other medicinal products for pain.
- Cochrane review: Oxycodone for neuropathic pain and fibromyalgia in adults
- BNF changes to haloperidol maximum dose
- A new fentanyl sublingual tablet launched in UK
- Tapentadol oral solution launched in UK
- A new oxycodone m/r tablet launched in UK
- A new oxycodone immediate-release generic capsule launched in UK
- Cochrane review: Heparin for perioperative thromboprophylaxis in patients with cancer
- Class 2 Medicines Recall: Midazolam buccal liquid 10mg/mL (unauthorized product)
- New drug driving offence - Department for Transport guidance
- Reminder of risk of life-threatening harm from accidental exposure to fentanyl patches