Alembic Pharmaceuticals Secures US FDA Tentative Approval for Ivosidenib Tablets, 250 mg

Alembic Pharmaceuticals Limited has informed the stock exchanges that the company has obtained tentative approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) concerning Ivosidenib Tablets, 250 mg. This approved ANDA is deemed therapeutically equivalent to Tibsovo Tablets, 250 mg, the reference listed drug product (RLD) marketed by Servier Pharmaceuticals LLC (Servier).

Ivosidenib, an isocitrate dehydrogenase-1 (IDH1) inhibitor, is indicated for patients with a detectable IDH1 mutation confirmed by an FDA-approved test. Its uses include: (a) monotherapy for newly diagnosed acute myeloid leukemia (AML) in adults aged 75 years or older, or those with comorbidities unsuitable for intensive induction chemotherapy, (b) treatment of adult patients with relapsed or refractory AML, and (c) management of locally advanced or metastatic cholangiocarcinoma in previously treated adults.

According to IQVIA, Ivosidenib Tablets, 250 mg, are expected to reach a market size of US$ 114 million for the twelve months ending March 2024.

Alembic Pharmaceuticals Limited has accumulated a total of 207 ANDA approvals from the USFDA, comprising 179 final approvals and 28 tentative approvals.

Recently, on July 1, 2024, Alembic Pharmaceuticals Limited announced receiving tentative approval from the US FDA for its Abbreviated New Drug Application for Bosutinib Tablets in 100 mg and 500 mg strengths. This approved ANDA is therapeutically equivalent to Bosulif Tablets, 100 mg and 500 mg, marketed by PF Prism C.V. (PF Prism). Bosutinib tablets are indicated for treating Philadelphia chromosome-positive chronic myelogenous leukemia.

About Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited, a vertically integrated pharmaceutical company engaged in research and development, has been a leader in healthcare since 1907. The company manufactures and distributes generic pharmaceutical products globally. Their advanced research and manufacturing facilities are approved by regulatory authorities in several developed countries, including the USFDA. Alembic is renowned as a leading provider of branded generics in India, with its products well-regarded among healthcare professionals and patients alike, marketed through a dedicated team of over 5,000 professionals.

On July 4, 2024, the share price of Alembic Pharmaceuticals Ltd opened at ₹960.50, touching the day’s high at ₹989.00, as of 12:34 PM on the NSE.

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