Hikma receives FDA approval for Fluphenazine Decanoate Injection
London, 4 May 2016 – 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 that its supplemental Abbreviated New Drug Application (sANDA) for Fluphenazine Decanoate Injection USP, 125mg/5 mL (25 mg/mL) multiple-dose vial has been approved by the U.S. Food and Drug Administration (FDA).
Flphenazine Deconate Injection is a neuroleptic drug used in the treatment of chronic pysychosis. According to IMS Health, sales of Fluphenazine Deconate Injection in the US market were approximately $23 million for the 12 months ending March 2016.
Said Darwazah, Chairman and CEO of Hikma, said, “We are very pleased this product has been approved for the US market. We continue to leverage our strong R&D, regulatory and high-quality manufacturing capabilities, and remain committed to prioritising the re-introduction of Bedford products for patients in need.”
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Hikma Pharmaceuticals PLC
| Susan Ringdal, VP Corporate Strategy and Investor Relations
| +44 (0)20 7399 2760/ +44 7776 477050
| Zeena Murad, Investor Relations Manager
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| Ben Atwell/ Matthew Cole
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Hikma Pharmaceuticals PLC is a fast growing multinational group focused on developing, manufacturing and marketing a broad range of both branded and non-branded generic and in-licensed products. Hikma operates through three businesses: “Injectables”, “Branded” and “Generics”, based principally in the United States, the Middle East and North Africa (MENA) and Europe. In 2015, Hikma achieved revenues of $1,440 million and profit attributable to shareholders of $252 million.