Drug Approval | January 16, 2025
Alembic announces USFDA final approval for Brexpiprazole Tablets
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets
Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
A first-in-class muscarinic agonist for the treatment of schizophrenia in adults
Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for treatment of schizophrenia
Emraclidine, a potential best-in-class, next-generation antipsychotic, is in trials designed to be registration enabling for schizophrenia
KarXT, Karuna’s lead asset, is a potential first-in-class treatment for Schizophrenia
Chlorpromazine Hydrochloride Injection is used to treat certain mental/mood disorders
Transaction delivers KarXT, a first-in-class M1/ M4 muscarinic receptor agonist with differentiated efficacy and safety
Phase 3 data expected in the second half of 2024
The company has received six final approvals that includes Chlorpromazine Hydrochloride Tablets
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