FDA lifts liver injury risk boxed warning from Gilead’s Letairis
FOSTER CITY, Calif. — Gilead on Friday announced that the Food and Drug Administration has removed a boxed warning about a possible liver injury risk caused by the drug maker’s hypertension treatment.
Gilead said the FDA approved a change to the prescribing information for Letairis (ambrisentan 5-mg and 10-mg tablets), the company’s once-daily treatment of pulmonary arterial hypertension.
The announcement followed the FDA’s review of post-marketing data, which found that during 12-week controlled clinical trials, the incidence of liver function abnormalities was 0% on Letairis and 2.3% on placebo among patients. In conjunction with this label update, PAH patients receiving Letairis no longer are required to obtain monthly liver function tests.
Gilead did note, however, that the drug will continue to carry a boxed warning, since it is contraindicated in pregnancy.
Eisai’s Banzel OKed as epilepsy treatment
WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a drug made by Eisai to treat a rare form of epilepsy, the drug maker said Friday.
The FDA approved Banzel (rufinamide) oral suspension for the treatment of seizures in children and adults with Lennox-Gastaut syndrome. The condition, also called LGS, affects 1% to 4% of children with epilepsy.
“This new formulation provides an option for patients who may prefer a liquid or find it difficult to take the medication in tablet form,” Eisai president and CEO Lonnel Coats said.
Hospira launches catalog of U.S. products on website
LAKE FOREST, Ill. — Hospira launched a new online resource that catalogs all of its products available in the United States.
Hospira said that the U.S. product catalog, available at Hospira.com/catalog, allows customers, including healthcare facilities and medical care providers, to search Hospira’s more than 1,200 products in a variety of ways: alphabetically, by product name, by list number or by therapeutic class.
"In designing the website, we focused on providing customers with access to a broad array of product information, while at the same time ensuring [that] the ability to search for information is both simple and intuitive," said Thomas Moore, president, U.S. for Hospira. "Our vision is to provide customers a comprehensive resource where they can research, experience and order products."
Click here to visit the site.