XTL granted orphan drug designation for multiple myeloma treatment
HERZLIYA, Israel — The Food and Drug Administration has given orphan drug designation to an investigational treatment for multiple myeloma, a blood cell cancer, that soon will enter mid-stage development.
XTL announced that the FDA had granted the designation to its recombinant human erythropoietin, or rHuEPO drug, for which the company soon will start phase-2 clinical trials.
The FDA gives orphan drug designation to treatments for diseases that affect fewer than 200,000 people in the United States per year.
While an orphan drug still must undergo the agency’s standard regulatory approval procedures, the designation entitles it to extended market exclusivity periods, tax credits for research and development expenses and exemptions from payment of commissions to the FDA.
Actavis’ generic Aricept gets FDA nod
MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic treatment for Alzheimer’s disease made by Actavis, the drug maker said Tuesday.
The FDA approved the company’s donepezil hydrochloride tablets in the 5-mg and 10-mg strengths, a generic version of Eisai and Pfizer’s Aricept. Donepezil hydrochloride tablets in the two strengths had sales of about $2.3 billion during the 12-month period ended in March, according to IMS Health.
Kroger promotes fuel savings
CINCINNATI — Kroger said that its family of stores is offering new ways for its customers to save on gas.
The retailer said that customers can earn fuel discounts when they purchase select gift cards, and also when they fill certain eligible prescriptions.
Kroger noted that the discounts vary by state and that its prescription fuel savings promotion is not being offered to Arkansas pharmacy customers.
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