Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The FDA has once again issued an approvable letter requesting more information on Valeant Pharmaceuticals treatment for Parkinson's disease, Zelapar. The FDA request is likely to cause a further delay in the path to market for the drug.
Subscribe to our email newsletter
In January of this year, the company submitted a complete response to a previous approvable letter from the FDA for Zelapar following the successful completion of two safety studies that the FDA indicated would be required for its approval.
However, having reviewed the additional information provided in the company’s response to the first approvable letter, it appears that the FDA is still not sufficiently satisfied to give the drug its final go ahead.
The company says that it plans to meet with the FDA promptly to discuss and resolve these matters.
Zelapar is under review by the FDA as an oral tablet using the patented Zydis fast-dissolving technology and is being developed as an adjunct treatment in the management of patients with Parkinson’s disease being treated with levodopa/carbidopa.