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Aurobindo Pharma arm gets U.S. FDA nod for generic of BMS' cancer drug

Aurobindo Pharma arm gets U.S. FDA nod for generic of BMS' cancer drug

The Hindu24-04-2025

Aurobindo Pharma subsidiary Eugia Pharma Specialities has received final approval from the U.S. Food and Drug Administration (U.S. FDA) to manufacture and market Dasatinib Tablets in different strengths.
Bioequivalent and therapeutically equivalent to the reference listed drug Sprycel Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol-Myers Squibb Company (BMS), the product is expected to be launched by June. The approved product has an estimated market size of $1.8 billion for the twelve months ending February 2025, Aurobindo said, citing IQVIA MAT numbers.
Dasatinib Tablets is indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia in chronic phase; adults with chronic, accelerated or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy; and adults with Ph+ acute lymphoblastic leukaemia with resistance or intolerance to prior therapy, the company said.
This is the 181st ANDA approval, including nine tentative approvals received, out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oncology oral and sterile specialty products.

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API prices fall sharply, easing pressure on India's pharmaceutical industry
API prices fall sharply, easing pressure on India's pharmaceutical industry

Time of India

time4 days ago

  • Time of India

API prices fall sharply, easing pressure on India's pharmaceutical industry

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Hindustan Times

time5 days ago

  • Hindustan Times

US faces vape shortage as China tariffs, seizures hit Geek Bar

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Stocks to buy: Lupin, Aurobindo, Max Healthcare among Axis Sec's top pharma & hospital picks post strong Q4
Stocks to buy: Lupin, Aurobindo, Max Healthcare among Axis Sec's top pharma & hospital picks post strong Q4

Mint

time5 days ago

  • Mint

Stocks to buy: Lupin, Aurobindo, Max Healthcare among Axis Sec's top pharma & hospital picks post strong Q4

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