Roxane Labs gets tentative approval for generic Hyzaar
ROCKVILLE, Md. Generic drug maker Roxane Labs has received tentative approval for a generic version of a drug used to treat hypertension, according to Food and Drug Administration records.
The FDA gave Roxane tentative approval for losartan potassium and hydrochlorothiazide tablets in the 50-mg and 12.5-mg and 100-mg and 25-mg strengths. The tablets are a generic version of Merck & Co.’s Hyzaar.
Hyzaar and Cozaar, which contains losartan potassium only, had combined global sales of $3.6 billion in 2008, according to Merck financial data.
Governments vie for GSK flu vaccine
LONDON Several governments have placed orders with GlaxoSmithKline for a candidate vaccine for the A (H1N1) influenza virus, popularly known as swine flu, the British drug maker announced.
GSK said it will manufacture the new vaccine once the World Health Organization makes the virus seed available, and it expects the first doses to be available six months later.
As of Monday, the influenza strain had infected 5,123 people and caused five deaths in the United States, according to the Centers for Disease Control and Prevention. Many public health experts fear that the virus could mutate and return in more virulent form when the Northern Hemisphere enters its flu season later in the year.
Shire to expand assistance program for UC patients
PHILADELPHIA A British drug maker announced Monday that it would expand its patient assistance program for patients with ulcerative colitis.
Shire said that UC patients taking Lialda (mesalamine delayed-release tablets) or Pentasa (mesalamine extended-release capsules) and who became unemployed this year can receive their medication at no cost throughout the rest of the year.
“We are committed to helping UC patients better manage their condition,” Shire gastrointestinal business SVP Roger Adsett stated. “Offering greater financial support to those who may be struggling due to the current economic climate through our expanded Shire CARES PAP is a natural extension of the Shire mission.”
Last week, Pfizer announced that it would begin offering drugs for free to patients with prescriptions to Pfizer drugs who lost their jobs this year.