Duloxetine Sandoz: Withdrawal of the marketing authorisation application

Duloxetine Sandoz is a medicine that contains the active substance duloxetine. It was to be available as gastroresistant capsules (capsules whose contents are not broken down in the stomach and release the medicine in the intestine) containing 30 or 60 mg of duloxetine.

Duloxetine Sandoz was developed as a 'generic medicine'. This means that Duloxetine Sandoz is similar to a 'reference medicine' already authorised in the European Union (EU) called Cymbalta

Duloxetine Sandoz was to be used to treat major depression, pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes) and generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).

The active substance in Duloxetine Sandoz, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor. It works by preventing the neurotransmitters serotonin and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.

Neurotransmitters are chemicals that allow nerve cells to communicate with one another. By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters available for communication between the cells. Since these neurotransmitters are involved in maintaining high mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.

Because Duloxetine Sandoz is a generic medicine, the company had presented results of tests to determine that Duloxetine Sandoz is bioequivalent to the reference medicine, Cymbalta. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions. The company had not yet responded to the questions at the time of the withdrawal.

Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns about whether the two studies conducted to show bioequivalence between the medicine and the reference product had been carried out in accordance with guidelines for Good Clinical Practice (GCP) and was of the provisional opinion that Duloxetine Sandoz could not have been approved for the treatment of depression, diabetic nerve pain and generalised anxiety disorder.

In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing its application because of the identification of GCP issues.