The U.S. Food and Drug Administration rejected Eagle Pharmaceuticals Inc's drug to prevent blood clots in certain patients undergoing heart surgery.
The drug, Kangio, is a ready-to-use version of The Medicines Co's blood clot preventer Angiomax, which is also to be taken with aspirin.
Kangio contains the same active ingredient as Angiomax, but eliminates the need for dilution. Angiomax must be reconstituted with water and then further diluted before it can be administered.
The regulator did not approve the marketing application for Kangio in its present form and requested additional information, the drugmaker said on Friday.
Angiomax was approved in the year 2000 to prevent blood clots in patients undergoing percutaneous coronary intervention (PCI) or angioplasty, a procedure to widen narrowed or obstructed arteries in the heart.
Heart disease is the leading cause of deaths in the United States, accounting for one in every seven, according to the American Heart Association.
The Medicines Co has been struggling since it lost patent protection for its flagship drug, which led the company to review strategic options including a potential sale of the entire company.
Eagle Pharma said it would work directly with the FDA to determine a path forward to address the health regulator's comments.
Eagle Pharma's shares were down about 20 percent at $42.97 in light premarket trading on Friday.
(Reporting by Rosmi Shaji in Bengaluru; Editing by Anupama Dwivedi)