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Daewoong wins nod for first generic version of Ibrance tab

By Lee, Tak-Sun | translator Hong, Ji Yeon

24.10.08 05:35:22

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Has acquired priority marketing authorization following success in patent nullification

Kwang Dong set to launch generic in capsule formulation¡¦set to launch in 2027


Daewoong's first generic for Pfizer's breast cancer treatment, 'Ibrance Tab,' has been approved. Due to the successful patent nullification, the company received priority marketing authorization. The first generic can be launched in March 23rd, 2027, when the product patent expires.

The Ministry of Food and Drug Safety (MFDS) has granted approval of Daewoong's "Ranclib tab" 75 mg, 100 mg, and 125 mg. This drug can be used to treat hormone receptor (HR)-positive or HER2-negative metastatic or advanced breast cancer.

It is used in combination with aromatase inhibitor as first-line endocrine therapy in women or in combination with fulvestrant after endocrine therapy in women with advanced

Lee, Tak-Sun(hooggasi2@dailypharm.com)
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