Alembic Pharmaceuticals receives tentative US FDA approval for Ivosidenib Tablets equivalent to Servier's Tibsovo Tablets.
Alembic Pharmaceuticals receives tentative US FDA approval for its ANDA for Ivosidenib Tablets, equivalent to Servier Pharmaceuticals' Tibsovo Tablets. Ivosidenib targets IDH1 mutation in patients with Acute Myeloid Leukemia (AML) and metastatic cholangiocarcinoma. The estimated market size for Ivosidenib Tablets is $114m for the 12 months ending March 2024. Alembic has 207 total ANDA approvals from the USFDA.
July 04, 2024
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