FDA ISSUES 'APPROVABLE LETTER' FOR NOVARTIS' PAGET'S DISEASE DRUG

Novartis has received an FDA "approvable letter" for its zoledronic acid (5 mg infusion), a treatment for Paget's disease -- a chronic and sometimes painful bone disorder affecting more than one million people in the U.S.

Zoledronic acid, which goes under the trade name Aclasta, already has been approved in 41 countries for the treatment of Paget's disease. The condition can also lead to osteoarthritis, kidney stones, and heart disease.

The "approvable letter" is a notification that the FDA is prepared to approve the drug. The letter contains conditions the applicant must meet prior to obtaining final U.S. marketing approval. This is the second approvable letter received for zoledronic acid for this indication.