NEW YORK (TheStreet) --Shares of Adamis Pharmaceuticals (ADMP - Get Report) are falling by 53.16% to $4.15 on heavy trading volume on Monday morning, as the FDA rejected the pharmaceutical company's emergency drug for severe allergic reactions.
The company announced earlier this morning that following the close of trading on Friday it received a complete response letter from the FDA regarding its new drug application for its epinephrine injection product.
The prefilled single dose syringe is for the treatment of the severe allergic reaction known as anaphylaxis.
The FDA wants Adamis to expand two studies on the drug in order to support its approval of the product. This is the second time the FDA rejected the company's epinephrine injection.
Adamis is expecting it will finish the expanded test and deliver the data to the FDA by the second half of the year.