January 13, 2009 / 11:48 AM / 11 years ago

UPDATE 1-FDA declines to approve OTC heartburn drug: Santarus

Jan 13 (Reuters) - Santarus Inc SNTS.O, a specialty pharmaceutical company, said U.S. health regulators declined to approve the marketing application for the over-the-counter version of its heartburn drug Zegerid submitted by partner Schering-Plough Corp SGP.N.

The company said Schering received a “complete response” letter, which outlined questions that the U.S. Food and Drug Administration identified during its review of the new drug application for OTC Zegerid.

The FDA issues complete response letters to companies when it is not ready to approve a drug. It does not publicly disclose what steps are needed to win approval.

Schering-Plough intends to continue to work closely with the FDA on a confidential basis to expeditiously address these questions, Santarus said in a statement.

Under the license agreement with Santarus, Schering-Plough is responsible for the development, manufacturing and marketing of Zegerid branded OTC products with the dosage strength of 20 mg of omeprazole for heartburn-related indications in the United States and Canada.

Shares of Santarus closed at $1.69 Monday on Nasdaq, while those of Schering-Plough closed at $17.84 on the New York Stock Exchange. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Amitha Rajan)

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