Richterʼs cariprazine wins expanded FDA approval


Hungaryʼs Gedeon Richter and Irish pharmaceutical firm Allergan have announced that the U.S. Food and Drug Administration (FDA) has approved Vraylar (cariprazine) for expanded use to treat depressive episodes associated with bipolar depression in adults.

“This approval represents an important milestone in our efforts to help patients and prescribing healthcare providers effectively manage bipolar I disorder, and demonstrates our ongoing focus on mental health,” said David Nicholson, chief research and development officer at Allergan, cited in a press release sent to the Budapest Business Journal. “We are committed to developing therapies for complex mental health disorders, including Vraylar, which is currently in phase III clinical trials for the treatment of Major Depressive Disorder.”

“This approval is considered a notable achievement in the development process of cariprazine, our flagship product,” said Dr. István Greiner, research director of Gedeon Richter. “We are pleased that more and more patient groups suffering from psychiatric disorders will get access to cariprazine as a treatment option.”

Vraylar is also approved in the United States for the treatment of manic or mixed episodes associated with bipolar I disorder in adults. The press release notes that there are nearly 11 million adults in the U.S. living with bipolar disorder, a condition that causes extreme shifts in mood, energy, and activity levels.

Cariprazine was Richterʼs third best-selling drug last year, after contraceptives and the nootropic Cavinton, state news wire MTI added. Vraylar was discovered and co-developed by Gedeon Richter and is licensed by Allergan in the U.S. and Canada.


E-scooters More Popular Than Bikes at eMag Analysis

E-scooters More Popular Than Bikes at eMag

Parliament Negates Mandatory Membership in MOK Parliament

Parliament Negates Mandatory Membership in MOK

Lidl Considering Home Delivery Retail

Lidl Considering Home Delivery

Service Restarted on Full Length of Metro Line M3 City

Service Restarted on Full Length of Metro Line M3


Producing journalism that is worthy of the name is a costly business. For 27 years, the publishers, editors and reporters of the Budapest Business Journal have striven to bring you business news that works, information that you can trust, that is factual, accurate and presented without fear or favor.
Newspaper organizations across the globe have struggled to find a business model that allows them to continue to excel, without compromising their ability to perform. Most recently, some have experimented with the idea of involving their most important stakeholders, their readers.
We would like to offer that same opportunity to our readers. We would like to invite you to help us deliver the quality business journalism you require. Hit our Support the BBJ button and you can choose the how much and how often you send us your contributions.