The US Food and Drug Administration (FDA) has declined to approve the nausea drug Zuplenz due to travel restrictions preventing site inspections in India.

Zuplenz is an oral soluble film containing the active ingredient ondansetron under development by Strativa Pharmaceuticals, a division of Par Pharma. Strativa has filed a new drug application (NDA) with the FDA for the prevention of nausea and vomiting associated with chemotherapy, radiotherapy and surgery. However, an agency wide travel restriction is currently in place which has prevented inspection of the clinical and analytical sites for the bioequivalence study in India.

The FDA has committed to inspecting the sites as soon as possible.

Ref: Strativa
http://www.parpharm....edia/NR_20100205.jsp

Ref: Reuters
http://www.reuters.c...dUSSGE6140IM20100205

Increasing need for local agents?