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HLB ¡®FDA meeting complete...no supplement data required'

By Son, Hyung-Min | translator Kang, Shin-Kook

24.07.05 05:01:32

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HLB¡¯s U.S. subsidiary Eleva and Jiangsu Hengrui Pharmaceuticals hold follow-up meeting regarding the receipt of the CRL

"Has faithfully submitted the required supplemental data...FDA recommended the company submit an application for reexamination"



HLB announced on the 2nd that it had completed the meeting with the U.S. Food and Drug Administration (FDA) to resume the license review of its new liver cancer drug.

At the meeting, which was attended by HLB's US subsidiary Eleva and Chinese partner Jiangsu Hengrui Pharmaceuticals, the FDA said it "strongly recommends submitting a re-examination application" to expedite the main review, which was delayed due to the issuance of the complete response letter (CRL), and delivered an official Post Action Letter (PAL) along its position.

HLB is interpreting the letter as meaning that "no additional supplementary information will be requested as Jiangsu Hengrui Pharmaceuticals has alr

Son, Hyung-Min(shm@dailypharm.com)
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