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Hikma launches Flucytosine Capsules USP in US
Hikma launches Flucytosine Capsules USP in US.
About this update from Hikma Pharmaceuticals Plc
[{"type":"text","content":"\n \nRNS Number : 4429V Hikma Pharmaceuticals Plc 03 November 2017 \n\nPRESS RELEASE\n \nHikma launches Flucytosine Capsules USP in the US market\n \nLondon, 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®1.\n \nWest-Ward's Flucytosine Capsules USP are indicated for the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus. \n \nAccording 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.\n \nBrian 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.\"\n \nImportant safety information\n \nFlucytosine 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. \n \nFlucytosine 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 f...