ADVERTISEMENT

FDA approves cariprazine resubmission

Deals

The U.S. Food and Drug Administration (FDA) acknowledged the receipt of Actavis' new drug application resubmission for the antipsychotic cariprazine, Hungarian drugmaker Gedeon Richter and Dublin-based peer Actavis reported today.

“We believe the resubmission of the cariprazine NDA includes the necessary data to address FDA’s comments and continue the review of this innovative treatment option,” said David Nicholson, Actavis Senior Vice President, Global Brands R&D.

Cariprazine (RGH-188) is an antipsychotic drug under development by Gedeon Richter and the license on development was obtained, together with exclusive commercial rights in the United States, by Forest Laboratories in 2004. Last year, Forest Laboratories was acquired by Actavis.

Paks II Work 'Rumbling Ahead,' Says Szijjártó Power

Paks II Work 'Rumbling Ahead,' Says Szijjártó

Hungary to Host Next EPC Summit Int’l Relations

Hungary to Host Next EPC Summit

New Tenants at Academia Offices Office Market

New Tenants at Academia Offices

Visitor Numbers, Guest Nights Climb in H1 Tourism

Visitor Numbers, Guest Nights Climb in H1

SUPPORT THE BUDAPEST BUSINESS JOURNAL

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.