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Alembic Pharmaceuticals gets USFDA tentative  nod for generic cancer  treatment drug

Share FacebookTwitterWhatsAppPinterestLinkedinCopy URLTelegramEmailTumblrReddItPrintKoo NEW DELHI, Jan 12:  Alembic Pharmaceuticals Ltd on Monday said it has received tentative approval from the US health regulator for its Bosutinib tablets used in the treatment of certain types of cancer. The tentative approval granted by the US Food & Drug Administration (USFDA) is for its supplemental abbreviated new drug application (sANDA) Bosutinib tablets of strength 400 mg, Alembic said in a regulatory filing. The approved ANDA is therapeutically equivalent to the reference listed drug product, Bosulif tablets, 400 mg, of PF Prism CV, it added.

Alembic Pharmaceuticals gets USFDA tentative  nod for generic cancer  treatment drug

Credit: Dailyexcelsior

Key Highlights

  • Bosutinib is indicated for the treatment of adult patients with “chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy”.
  • It is also used for treatment of  “adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy”, the company said.
  • Alembic said it had previously received final approval for its ANDA Bosutinib tablets, 100 mg and 500mg.
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Sources

  1. Alembic Pharmaceuticals gets USFDA tentative  nod for generic cancer  treatment drug

This quick summary is automatically generated using AI based on reports from multiple news sources. The content has not been reviewed or verified by humans. For complete details, accuracy, and context, please refer to the original published articles.

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