July 3 (Reuters) - The U.S. Food and Drug Administration (FDA) has declined to approve Amneal Pharmaceuticals' (AMRX.N) drug designed to help control symptoms in Parkinson's disease patients for a longer duration, citing inadequate safety data.
The complete response letter comes as a surprise, said Barclays analyst Balaji Prasad.
The decision does not impact 2023 forecast as it did not include the revenue from the drug, the company said.
Amneal has another Parkinson's drug, Rytary, on the market but has been struggling to gain a foothold in the treatment space.
Only 4% of patients use the drug since its approval in 2015, as per company estimates.
Persons:
Balaji Prasad, Amneal, Raghav Mahobe, Khushi, Sriparna Roy, Pooja Desai, Shweta Agarwal, Sriraj
Organizations:
U.S . Food, Drug Administration, Amneal Pharmaceuticals, FDA, Barclays, Thomson
Locations:
U.S, Bengaluru