Zypadhera: “undetermined” re-availability of the antipsychotic drug

Supply difficulties for the antipsychotic drug Zypadhera have worsened to the point that the date of its re-availability is now "undetermined," the French Medicines Safety Agency (ANSM) announced on Wednesday, August 13. Zypadhera, an olanzapine-based treatment given in injectable form to adult schizophrenic patients, has been experiencing supply problems in Europe since May 2024.

The ANSM said in a press release that it had been "informed by the Cheplapharm laboratory of delays in the supply of Zypadhera, linked to additional manufacturing and supply chain difficulties at its production site." In addition, "two batches could not be marketed due to a quality defect," the health agency added. The tensions mainly concern the 300 mg and 405 mg dosages.

The laboratory, which had planned in July to make the drug available again from September 2025, has announced that the date for resuming supplies remains "undetermined" for the time being, underlines the ANSM.

The agency is asking doctors to stop starting new treatments with Zypadhera so that patients already on treatment can continue to benefit from it. The ANSM is also asking them to consider switching to the oral form of olanzapine for patients for whom this is possible, or to consider another antipsychotic if a long-acting injectable form is necessary.

The oral form of the medication requires more frequent use. The risk is that the patient, often mentally unstable, will no longer adhere to their treatment assiduously.

Imported Zypadhera 300 mg has been made available since June 2025 on a transitional and exceptional basis to meet the needs of patients in France, according to the ANSM.

Difficulties in supplying psychotropic drugs persist in France, particularly for quietapine, a neuroleptic often prescribed to treat schizophrenia, bipolar disorder and certain depressions.