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April 15 (Reuters) - The U.S. Food and Drug Administrationapproved GlaxoSmithKline Plc's Tanzeum injection fortreating adults with type 2 diabetes, in combination with dietand exercise.
Tanzeum will carry a warning on its label that tumors of thethyroid gland were observed in rodent studies with some drugsbelonging to the same class. However, it is unknown whetherTanzeum causes thyroid C-cell tumors, the FDA said on itswebsite. (http://link.reuters.com/jyp58v)
The regulator also asked for post-marketing studies to testthe drug's dosing, efficacy and safety in children, and to checkfor heart-related risks.
It also asked the company to identify any increase inmedullary thyroid cancer cases related to Tanzeum.
The once-weekly drug, generically known as albiglutide, wasapproved last month in Europe, where it will be marketed asEperzan.
Analysts expect the drug to hit $430 million in sales by2018, according to Thomson Reuters data.
Tanzeum belongs to the same class of injectable GLP-1 drugsas Victoza from Novo Nordisk and Byetta and Bydureonfrom AstraZeneca.
Type 2 diabetes affects about 24 million people and accountsfor more than 90 percent of diabetes cases diagnosed in theUnited States, the FDA said.
GSK shares were up slightly at 1,547 pounds in lateafternoon trade on the London Stock Exchange. (Reporting by Esha Dey in Bangalore; Editing by SaumyadebChakrabarty)