KemPharm says FDA does not approve its painkiller

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed

(Reuters) - 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.

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