Hikma Pharmaceuticals Plc Update on ANDA for Generic Advair Diskus® (5712U)
April 08 2016 - 2:00AM
UK Regulatory
TIDMHIK
RNS Number : 5712U
Hikma Pharmaceuticals Plc
08 April 2016
Hikma's ANDA for Generic Advair Diskus(R) accepted for filing by
FDA
London, 8 April 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, today confirms that its abbreviated new drug
application (ANDA) for fluticasone propionate and salmeterol
inhalation powder has been accepted for filing by the U.S. Food and
Drug Administration (FDA).
The FDA provided Hikma, through its wholly-owned subsidiary,
West-Ward Pharmaceuticals, a GDUFA goal date of May 10, 2017. This
product is the generic version of GlaxoSmithKline's Advair
Diskus(R), which is indicated for the treatment of asthma and the
maintenance treatment of airflow obstruction and reducing
exacerbations in patients with chronic obstructive pulmonary
disease (COPD) and is delivered using Vectura's proprietary dry
powder inhaler and formulation technology.
Said Darwazah, Chairman and CEO of Hikma said, "We are very
pleased to have achieved this important milestone in the
development of generic Advair Diskus(R). With our partner, Vectura,
our team has worked closely with the FDA to ensure the quality of
the ANDA submission. Our interactions with the FDA have helped
clarify the requirements for the development of a robust, patient
friendly, (AB-rated) substitutable generic product for Advair
Diskus(R). We look forward to bringing to market this very
important product for patients."
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Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal, VP Corporate +44 (0)20 7399 2760/ +44
Strategy and Investor Relations 7776 477050
Zeena Murad, Investor Relations +44 (0) 20 7399 2768/ +44
Manager 7771 665277
FTI Consulting
Ben Atwell/ Matthew Cole
/ Julia Phillips +44 (0)20 3727 1000
About Hikma
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.
This information is provided by RNS
The company news service from the London Stock Exchange
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