Dong-A ST first to pay the raised new drug approval fee?
By Lee, Hye-Kyung | translator Alice Kang
25.01.07 05:16:42
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Applied for a prior consultation for its new epilepsy drug cenobamate¡¦is required to submit an application in 3 months
Developed by SK Biopharm, the two companies signed a licensing agreement last year
With the new drug approval fee raised to KRW 410 million on Jan. 1 this year, the industry is eyeing whether Dong-A ST will become the first to apply for marketing authorization and pay the raised new drug approval fee.
According to industry sources on the 7th, Dong-A ST applied for a prior consultation before applying for marketing authorization for its new drug cenobamate for epilepsy at the end of last year. Cenobamate is known under the brand name ¡®Xcopri¡¯ in the U.S.
The prior consultation is a procedure introduced when the fee was increased as an ¡®innovative measure for new drug approval,¡¯ and is only available once for new drugs that are scheduled to apply for marketing authorizat
Lee, Hye-Kyung(hgrace7@dailypharm.com)
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