Showing posts sorted by relevance for query vortioxetine. Sort by date Show all posts
Showing posts sorted by relevance for query vortioxetine. Sort by date Show all posts

Thursday, September 29, 2016

Brintellix (vortioxetine) Renamed Trintellix (vortioxetine) in U.S. to Avoid Name Confusion

In continuation of my update on vortioxetine

Vortioxetine.svg

Takeda Pharmaceuticals U.S.A., Inc., a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502) (collectively “Takeda”), and Lundbeck announced today that Brintellix(vortioxetine) will be marketed in the United States under the new name Trintellix(vortioxetine) starting in June of 2016. The vortioxetine product is a prescription medicine approved to treat Major Depressive Disorder (MDD) in adults. The formulation, indication and dosages of Trintellix remain the same as that of Brintellix.

This name change comes after receiving reports of name confusion in the marketplace between Brintellix and the anti-blood clotting therapy Brilinta® (ticagrelor). In response, Takeda and Lundbeck, in coordination with the U.S. Food and Drug Administration (FDA), determined that a name change would be the best way to minimize future product name confusion by patients and providers.
“Though the original name was fully screened prior to launch, after learning about name confusion issues with Brintellix and Brilinta, we quickly took action to educate healthcare professionals and pharmacies about the potential for name confusion,” said Thomas Harris, Vice President Global Regulatory Affairs at Takeda. “Takeda and Lundbeck then proactively worked with the FDA and decided to change the name of our product as we believe this action will help minimize future risk of patients inadvertently receiving the incorrect medication.”
“Even though the name of the product is changing, together with Takeda, we will work to ensure providers and patients are aware that the vortioxetine product itself has not changed. It’s still the same medication, dosing and expected outcomes,” said Gregg Pratt, Vice President, U.S. Regulatory Affairs at Lundbeck.
“Patient safety is our utmost priority at Takeda and Lundbeck,” said Ramona Sequeira, President, U.S. Business Unit at Takeda. “Together, with our partners at Lundbeck, we will initiate a robust communication campaign and actively work to ensure that patients, healthcare professionals and pharmacies have uninterrupted access to this important medication. We believe these actions speak to our goals of building our business around patients, trust and reputation.”
During the transition period this summer, healthcare providers can still prescribe, and patients will still have access to, the product under its current brand name. The newly named Trintellix will be available in June 2016. Additionally, markings on the Trintellix tablets will be identical to the markings on tablets prior to the name change. Trintellix will have new National Drug Code (NDC) numbers associated with the product. Individuals and healthcare professionals who have questions about Brintellix, Trintellix and/or the name change, should contact Takeda at 1-877-TAKEDA-7.
Errors involving Brintellix/Trintellix or any other products should be reported to the FDA MedWatch program online at www.fda.gov/medwatch.

About Brintellix (vortioxetine), now known as Trintellix (vortioxetine), in the United States


Friday, October 11, 2013

FDA Approves Brintellix to Treat Major Depressive Disorder

We know that, Vortioxetine (vor-tye-ox-e-teen, trade name Brintellix, previously known as Lu AA21004) is a novel atypical antidepressant made byLundbeck and Takeda. On September 30, 2013, it was approved approved by the U.S. FDA for the treatment of major depressive disorder (MDD) in adults.  Vortioxetine was also investigated as a treatment for generalized anxiety disorder (GAD).

Regulatory approval for the treatment of MDD for the European market has been filed in September 2012, for the United States in October 2012, and filing for Canada should follow. Filing for the Japanese market is expected in 2013.

The U.S. Food and Drug Administration recently approved Brintellix (vortioxetine) to treat adults with major depressive disorder.