* Says FDA cites travel restrictions on inspection of sites
* Says no issues related to study data found
* Says FDA to reschedule inspection as soon as possible
Feb 5 (Reuters) - Strativa Pharmaceuticals, a unit of Par Pharmaceutical Cos Inc, said the U.S. health regulator declined to approve its nausea drug Zuplenz, citing travel restrictions to India.
Strativa said the U.S. Food and Drug Administration (FDA) informed that it was unable to perform an inspection of the clinical and analytical sites for a bioequivalence study on the drug 'due to an agency-wide restriction on foreign travel in India.'
However, the company said no issues related to the study data or film product were identified.
Zuplenz, an oral soluble film, is being developed for the prevention of nausea and vomiting associated with chemotherapy, radiotherapy and surgery.
The company said the FDA will schedule and perform an inspection of the sites as soon as possible.
Shares of Par Pharmaceauticals closed at $25.99 Friday on Nasdaq.
(Reporting by Krishnakali Sengupta in Bangalore; Editing by Gopakumar Warrier) Keywords: PARPHARMA/ (krishnakali.sengupta@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: krishnakali.sengupta.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
* Says no issues related to study data found
* Says FDA to reschedule inspection as soon as possible
Feb 5 (Reuters) - Strativa Pharmaceuticals, a unit of Par Pharmaceutical Cos Inc, said the U.S. health regulator declined to approve its nausea drug Zuplenz, citing travel restrictions to India.
Strativa said the U.S. Food and Drug Administration (FDA) informed that it was unable to perform an inspection of the clinical and analytical sites for a bioequivalence study on the drug 'due to an agency-wide restriction on foreign travel in India.'
However, the company said no issues related to the study data or film product were identified.
Zuplenz, an oral soluble film, is being developed for the prevention of nausea and vomiting associated with chemotherapy, radiotherapy and surgery.
The company said the FDA will schedule and perform an inspection of the sites as soon as possible.
Shares of Par Pharmaceauticals closed at $25.99 Friday on Nasdaq.
(Reporting by Krishnakali Sengupta in Bangalore; Editing by Gopakumar Warrier) Keywords: PARPHARMA/ (krishnakali.sengupta@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: krishnakali.sengupta.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.