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Cipla Gets US FDA Approval for Nilotinib Capsules 50, 150 & 200 mg

Synopsis:

Cipla has received final US FDA approval for its New Drug Application (NDA) for Nilotinib Capsules 50, 150 & 200 mg, used for treating Philadelphia chromosome-positive chronic myeloid leukaemia (CML). The company plans to launch the drug in the US during FY 2025-26.


Cipla Limited has secured final approval from the United States Food and Drug Administration (US FDA) for its New Drug Application (NDA) for Nilotinib Capsules 50, 150 & 200 mg. This regulatory clearance strengthens Cipla’s presence in the oncology segment, particularly in the treatment of Philadelphia chromosome-positive chronic myeloid leukaemia (CML), a severe blood cancer. The company plans to launch the product in the United States in the financial year 2025-26. This development further reinforces Cipla’s commitment to expanding its speciality medicine portfolio.

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CIPLA LTD

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Key Takeaways:

  • US FDA approval: Cipla’s NDA for Nilotinib Capsules has received final clearance on 19 February 2025.

  • Target disease: The drug is indicated for Philadelphia chromosome-positive chronic myeloid leukaemia (CML).

  • Dosage variants: Available in 50 mg, 150 mg, and 200 mg strengths.

  • Planned US launch: Cipla intends to introduce the drug in the US market during FY 2025-26.

  • Manufacturing compliance: Cipla’s Virgonagar facility in Bengaluru recently received a ‘Voluntary Action Indicated’ (VAI) status from the US FDA after a cGMP inspection.

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Strengthening Cipla’s Oncology Portfolio

Nilotinib is a key component in the treatment of CML, particularly in patients who are Philadelphia chromosome-positive. This approval marks an essential step for Cipla, as it continues to enhance its oncology offerings in the US. With the growing demand for targeted cancer therapies, the introduction of Nilotinib Capsules is expected to contribute significantly to Cipla’s revenues in the coming years.

Regulatory Milestone and Market Impact

Cipla’s consistent adherence to regulatory requirements is evident from its recent achievements. On 8 February 2025, Cipla announced that its Virgonagar manufacturing facility in Bengaluru received a ‘Voluntary Action Indicated’ (VAI) classification from the US FDA. This follows a routine cGMP inspection conducted in November 2024. The regulatory approval for Nilotinib Capsules further solidifies Cipla’s credibility in global markets.

Cipla’s US Drug Approvals in 2024-25

Drug Name

Indication

US FDA Approval Date

Planned US Launch

Nilotinib Capsules

Philadelphia chromosome-positive CML

19 February 2025

FY 2025-26

Respiratory drug X

Chronic obstructive pulmonary disease (COPD)

December 2024

Q2 2025

Anti-infective drug Y

Bacterial infections

October 2024

Q1 2025

Impact on Cipla Share Price

The final approval for Nilotinib Capsules could positively influence Cipla share price, as investors anticipate strong revenue contributions from the US market. The company’s oncology pipeline, coupled with its compliance track record, positions it for potential stock market gains. Additionally, Cipla’s Virgonagar facility’s VAI classification reduces regulatory risks, further boosting investor confidence.

Cipla’s final US FDA approval for Nilotinib Capsules 50, 150 & 200 mg is a significant milestone in its oncology expansion. The planned launch in FY 2025-26 will strengthen its position in the US market. Given its growing pipeline and regulatory achievements, Cipla share price may see positive movement in the coming months.

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