Hikma Pharmaceuticals Plc Hikma launches Flucytosine Capsules USP in US
November 03 2017 - 5:00AM
RNS Non-Regulatory
TIDMHIK
Hikma Pharmaceuticals Plc
03 November 2017
PRESS RELEASE
Hikma launches Flucytosine Capsules USP in the US market
London, 3 November 2017 - Hikma Pharmaceuticals PLC (Hikma)
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody's /
BB+ S&P, both stable) announces that its wholly owned US
subsidiary, West-Ward Pharmaceuticals Corp. (West-Ward), has
launched Flucytosine Capsules USP in 250mg and 500mg strengths, the
generic equivalents to Ancobon(R)(1) .
West-Ward's Flucytosine Capsules USP are indicated for the
treatment of serious infections caused by susceptible strains of
Candida and/or Cryptococcus.
According to IMS Health, US sales of Flucytosine Capsules USP in
250mg and 500mg strengths were approximately $47 million for the 12
months ending September 2017.
Brian Hoffmann, President of Generics said, "We are very pleased
to be launching this product from the West-Ward Columbus portfolio.
We have an excellent pipeline of differentiated products that we
expect will drive future growth."
Important safety information
Flucytosine Capsules should be used with extreme caution in
patients with impaired renal function. Since Flucytosine Capsules
are excreted primarily by the kidneys, renal impairment may lead to
accumulation of the drug. Flucytosine serum concentrations should
be monitored and dosage adjustments made in patients with renal
insufficiency. Flucytosine should be given with extreme caution to
patients with bone marrow depression. Bone marrow toxicity can be
irreversible and may lead to death in immunosuppressed patients.
Close monitoring of hematologic, renal and hepatic status of all
patients is essential.
Flucytosine Capsules are contraindicated in patients with a
known hypersensitivity to the drug. Severe adverse reactions have
been associated with the use of Flucytosine Capsules, including
cardiac arrest, cardiac toxicity, respiratory arrest, acute hepatic
injury, renal failure, cytopenia, convulsions, psychosis and
Lyell's syndrome. There have been no adequate and well controlled
studies of Flucytosine Capsules in pregnant women, but flucytosine
has shown teratogenic effects in animal studies. Due to the
potential for serious adverse reactions in nursing infants from
Flucytosine Capsules, a decision should be made whether to
discontinue nursing or discontinue the drug. The efficacy and
safety of Flucytosine Capsules has not been systematically studied
in pediatric patients. For additional information, please refer to
the Package Insert for full prescribing information, available on
https://dailymed.nlm.nih.gov/dailymed/.
-- ENDS --
Hikma Pharmaceuticals PLC
Susan Ringdal VP Corporate Strategy and Director of Investor
Relations +44 (0)20 7399 2760/ +44 7776 477050
West-Ward Pharmaceuticals Corp.
Keri Butler, Corporate Affairs and Communications +1 614 272
4774/ +1 614 214 6657
FTI Consulting
Ben Atwell/ Brett Pollard +44 (0)20 3727 1000
About Hikma
Hikma Pharmaceuticals PLC is a multinational pharmaceutical
group focused on developing, manufacturing and marketing a broad
range of both branded and non-branded generic and in-licensed
products. Hikma's operations are conducted through three
businesses: 'Injectables,' 'Generics' and 'Branded,' based
primarily in the Middle East and North Africa (MENA) region, where
it is a market leader, the United States and Europe. In 2016, Hikma
achieved revenues of $1,950 million and profit attributable to
shareholders of $155 million.
1 Ancobon is a registered trademark of Valeant Pharmaceuticals
International or its related companies
This information is provided by RNS
The company news service from the London Stock Exchange
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