FDA will hold diabetes drug Galvus

The American Food and Drug Administration (FDA) will extend their review of the anti-diabetes medicine galvus for an extra three months until the end of February 2007, according to manufacturer Novartis AG.
The move by the regulatory authority, that investigates each new drug application to ensure certain standards are imposed, follows additional data submitted by Novartis. The company apparently remains confident that Galvus is both efficient and safe for use amongst the diabetic population.
The FDA sometimes takes the option of extending the standard 10-month review period for new drug applications. This usually happens when the manufacturer submit large amounts of additional data towards the end of the review period. Galvus is the subject of some debate, following skin findings in a pre-clinical animal study.
Extensive trials of Galvus will continue, but the delay will influence the diabetes drug market, and will be good news for Merck, whose Januvia diabetes drug is expected to become a blockbuster.