Share of Aurobindo Pharma Ltd surged 4% on 23 April after the company’s wholly-owned subsidiary announced securing final approval from the US Food and Drug Administration (USFDA).
In its regulatory filing, the company said that its wholly-owned subsidiary, Eugia Pharma Specialities Ltd, received final approval from the USFDA to manufacture and market Dasatinib tablets that are used to treat leukaemia in adults and kids.
In its exchange filing, the company stated that Dasatinib Tablets may also be prescribed for:
- Newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in the chronic phase.
- Adults with chronic, accelerated, or blast phase (myeloid or lymphoid) Ph+ CML who are resistant or intolerant to previous treatments including imatinib.
- Adults with Ph+ acute lymphoblastic leukaemia (ALL) who are facing resistance or intolerance to prior therapies.
The approved medication targets an estimated market valued at $1.8 billion for the 12-month period ending February 2025.
The company aims to roll out Dasatinib in the first quarter of FY26.
Additionally, earlier this month, the Hyderabad-based pharmaceutical firm received final approval from the USFDA to manufacture and market Rivaroxaban Tablets USP, 2.5 mg, which is the generic version of Janssen Pharmaceuticals’ blockbuster drug Xarelto 2.5 mg.
The company plans to introduce this product in the first quarter of FY 25-26.
At 1:52 pm, the shares of Aurobindo Pharma were trading 4.58% higher at Rs 1,242.10 on NSE.
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