BUDAPEST, Hungary, April 10, 2024 /PRNewswire/ -- Cariprazine, an original antipsychotic drug developed by Hungarian pharmaceutical company Gedeon Richter Plc. is available in 64 countries and has become a multiple blockbuster in the US, with sales of nearly $3 billion. It is a unique achievement that a Hungarian drug candidate – discovered and developed locally – has been granted FDA and EU approvals, and the company already has several further molecules in its pipeline.
Aurobindo's Generic Cariprazine Receives Receives Approval in the U.S.
As AbbVie inches toward its big loss of exclusivity for Humira in early 2023, the company will have an important launch to help offset the biosim erosion.
NORTH CHICAGO, Ill., Dec. 16, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved VRAYLAR® (cariprazine) as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults. Supported by clinical data demonstrating efficacy and well-established tolerability, this additional indication provides a new option for adults who have a partial response to the treatment of an antidepressant.
BUDAPEST, Hungary, Oct. 18, 2022 /PRNewswire/ -- Between the 15-18th of October 2022, during the 35th Annual Meeting of the European College of Neuropsychopharmacology (ECNP), new analyses of cariprazine studies were presented by Gedeon Richter Plc. In the poster presentations it was shown that the incidence of adverse drug reactions with cariprazine decreased over time, higher doses of cariprazine do not seem to increase rescue medication use nor extrapyramidal symptom-related side effects, and that both 1.5 mg and 3.0 mg of cariprazine is an effective dose for the treatment of general symptoms of bipolar depression. Issues regarding polypharmacy, and the special needs of women with schizophrenia were also highlighted in an industry-sponsored product theater and satellite symposium.
Zydus's Generic Cariprazine HCL Receives Approval in the U.S.
NORTH CHICAGO, Ill., Feb. 22, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted a supplemental New Drug Application (sNDA) for cariprazine (VRAYLAR®) to the U.S. Food and Drug Administration (FDA) for the adjunctive treatment of major depressive disorder (MDD) in patients who are receiving ongoing antidepressant therapy. The submission is supported by results from previously announced clinical trials.
Teva's Generic Fluticasone & Salmeterol Receives Approval in the U.S.
Zydus Pharmaceuticals Inc has received tentative approval from the nUnited States Food and Drug Administration (FDA) to market Cariprazine nCapsules in the strengths of 1.5 mg, 3 mg, 4.5 mg and 6 mg, the company nnotified via a statement.