London, 4 November 2015 – Hikma Pharmaceuticals PLC (“Hikma”) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, announces it has received an approval from the U.S. Food and Drug Administration (“FDA”) for its supplemental Abbreviated New Drug Application (“sANDA”) for phentolamine mesylate (“phentolamine”) for injection USP, 5mg/vial and is today launching this product in the US market.
Phentolamine injection is indicated for the prevention or control of hypertensive episodes that may occur in patients with pheochromocytoma, as a result of stress or manipulation during preoperative preparation and surgical excision. It is also indicated for the prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine, as well as the diagnosis of pheochromocytoma by the phentolamine blocking test.
Phentolamine will be the third product previously marketed by Bedford Laboratories to be launched by Hikma in the United States, and is the first Bedford product to be approved from Hikma’s Portuguese facility. Phentolamine is also currently on the FDA’s Drug Shortages list.
Said Darwazah, Chairman and CEO of Hikma said, “We are making good progress with the transfer of the Bedford products to our manufacturing facilities, leveraging our strong R&D, regulatory and manufacturing capabilities. We are very pleased to be launching phentolamine in the US market and remain committed to prioritising the re-introduction of Bedford products for patients in need.”