KemPharm says FDA does not approve its painkiller
{{#rendered}} {{/rendered}}KemPharm Inc said the U.S. health regulator did not approve its abuse-deterrent version of a painkiller, sending the drug developer's shares down more than 30 pct in extended trade.
The U.S. Food and Drug Administration's decision on the company's marketing application for Apadaz was conveyed via a complete response letter.
Such letters typically outline concerns and conditions that must be addressed to gain regulatory approval.
{{#rendered}} {{/rendered}}KemPharm said it is evaluating points raised in the letter and intends to request a meeting with the FDA to discuss the way forward for the drug.
Shares of KemPharm closed at $6.29 on Monday.
(Reporting by Shailesh Kuber in Bengaluru; Editing by Shounak Dasgupta)