Targanta to get FDA decision on new drug by December

Targanta Therapeutics Corp. has passed a big milestone in its bid to gain regulatory approval for its lead antibiotic.

The Cambridge, Mass., company (Nasdaq: TARG) announced on Wednesday that the U.S. Food and Drug Administration had accepted the application for its drug oritavancin for standard review.

The FDA can just as easily send a drug back to the pharmaceutical company to seek more clinical trials or additional information. But "standard review" gets the process moving. The status means the FDA should make a decision either way by Dec. 8.

Targanta submitted its new drug application in early February. The company wants to use oritavancin to treat complicated skin infections, particularly those caused by drug-resistant bacteria.

With the FDA action, CEO Mark Leuchtenberger expects Targanta to begin building a commercial infrastructure, hopefully to start marketing oritavancin by mid-2009.
Targanta, meanwhile, plans to apply for regulatory approval in the European Union for its drug by later this year.

Source : www.bizjournals.com

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