Novartis has received an approvable letter from the US Food and Drug Administration (FDA) for zoledronic acid (5mg infusion), which is under review for the treatment of Paget's disease of the bone.
The approvable letter is a notification that the FDA is prepared to approve the drug and contains conditions that the applicant must meet prior to obtaining final US marketing approval. This is the second approvable letter received for zoledronic acid for this indication. In this case, the FDA has requested additional data from the ongoing clinical trial programme in osteoporosis, states a Novartis release.
Submission for osteoporosis in the US and EU remains planned for 2007. Zoledronic acid 5 mg, under the trade name Aclasta, has been approved in 41 countries worldwide, including the EU, for the treatment of Paget's disease.
Paget's disease is a chronic and sometimes painful disorder affecting more than one million people in the US.