(Reuters) -The U.S. Food and Drug Administration has declined to approve Milestone Pharmaceuticals’ nasal spray to treat a type of heart condition, the company said on Friday.
The health regulator did not raise any concerns related to the safety or efficacy of the spray, called Cardamyst, but highlighted two key chemistry, manufacturing and controls issues.
Shares of the company were halted in premarket trading.
(Reporting by Siddhi Mahatole and Puyaan Singh in Bengaluru; Editing by Shreya Biswas and Maju Samuel)
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