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Lyrica CR generics begin development...PMS expires next July

By Lee, Tak-Sun | translator Alice Kang

21.08.19 15:58:31

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Dasan Pharmaceutical receives first approval for bioequivalence test¡¦ 80 companies had applied for generics of Lyrica¡¯s immediate-release formulation



Development for generics of Pfizer¡¯s pain reliever ¡®Lyrica CR,¡¯ whose post-market surveillance (PMS) period expires in July next year, has begun.

Unlike Lyrica, which is taken twice a day, Lyrica CR is a once-daily formulation and is used for peripheral neuropathic pain in adults. With more than 80 pharmaceutical companies participating in the development of Lyrica generic, attention is focused on whether such avid interest will be shown for Lyrica CR as well.

On the 17th, the Ministry of Food and Drug Safety approved the bioequivalence study protocol for Dasan Pharmaceutical¡¯s DSP2102. The study will assess the bioequivalence of Dasan Pharmaceutical¡¯s ¡®DSP2102¡¯ and Pfizer Pharmac

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