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.