Ibj.com

Lilly’s Zyprexa injection probed by FDA after deaths

Eli Lilly and Co.’s injectable form of the antipsychotic Zyprexa is being investigated by U.S. regulators after two patients died three to four days after receiving the drug. The two patients, given ...
FierceBiotech

FDA Issues Not-Approvable Letter for Lilly's Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment

"We are disappointed by the FDA's decision and we are committed to ongoing discussions to better understand the agency's perspective regarding this recent case of excessive sedation and to define the ...
Drug Store News

FDA issues not-approvable letter to Eli Lilly for Zyprexa injection

INDIANAPOLIS Eli Lilly reported the receipt of a not-approvable letter on Thursday from the Food and Drug Administration for Zyprexa long-acting injection for the treatment and maintenance treatment ...
FiercePharma

FDA probes long-acting Zyprexa safety after 2 patients die

Two patients have died unexpectedly after their Zyprexa Relprevv injections, and the FDA is now investigating. The agency says the patients died three to four days after receiving "an appropriate dose ...
Medscape

FDA Approves Long-Acting Olanzapine Injection

December 15, 2009 — The US Food and Drug Administration (FDA) has approved olanzapine extended-release intramuscular injection (Zyprexa Relprevv, Eli Lilly & Company) for the treatment of ...
FierceBiotech

FDA Advisory Committee Supports Efficacy and Safety of Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment

In clinical trials, Zyprexa LAI had a safety profile similar to oral olanzapine, with the exception of post- injection excessive sedation events, which also include dizziness, confusion and altered ...
Monthly Prescribing Reference

FDA Finishes Review of Patient Deaths Post-Zyprexa Relprevv Injection

The Food and Drug Administration (FDA) stated that study results were inconclusive regarding the investigation of two deaths following the injection of Zyprexa Relprevv (olanzapine pamoate ...
TheStreet.com

FDA Rejects New Form of Lilly's Zyprexa

received a not approvable letter from the Food and Drug Administration for a new injection form of the schizophrenia treatment Zyprexa. Shares of Lilly were down 1.9% at $50.85 Thursday. Zyprexa, ...
Bloomberg L.P.

FDA Investigating Lilly’s Zyprexa Injection After Two Die

Eli Lilly & Co.’s injectable form of the antipsychotic Zyprexa is being investigated by U.S. regulators after two patients died three to four days after receiving the drug. The two patients, given ...
Daily Herald

FDA investigates Zyprexa Relprevv patient deaths

Federal regulators are investigating the deaths of two patients who received injections of a longer-lasting version of Eli Lilly’s antipsychotic Zyprexa. The Food and Drug Administration said Tuesday ...
Managed Healthcare Executive

Extended‑release olanzapine may improve adherence to treatments for schizophrenia

As treatment for schizophrenia changes, LAIs are becoming increasingly important as maintenance therapy. Teva's pursuit of an ...
Medscape

FDA Panel Finds Olanzapine Injection Safe, Effective, With Restrictions in Schizophrenia

February 12, 2008 — The Psychopharmacologic Drugs Advisory Committee of the Food and Drug Administration (FDA) voted unanimously that the investigational long-acting intramuscular injection form of ...