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
Granules now has a total of 67 ANDA approvals from the USFDA
The company plans to advance Ropanicant into double-blind, placebo-controlled Phase-2b clinical study in MDD patients, anticipated to start in early 2025
The primary objective was to evaluate safety and tolerability of Ropanicant in patients with MDD
Trazodone tablets are indicated for the treatment of major depressive disorder in adults
Emraclidine, a potential best-in-class, next-generation antipsychotic, is in trials designed to be registration enabling for schizophrenia
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac Tablets of Eli Lilly
Studies will Investigate Antidepressant Properties of Ketamir to Position for Initial IND Application in 2024
CB03 is a candidate drug for the treatment of ALS and other central nerve system (CNS) diseases
SMPA's diverse portfolio includes six marketed products and a robust pipeline of early- to late-stage assets
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