FDA advisory panel recommends approval of Factive for respiratory tract infections
SOUTH SAN FRANCISCO, CAL., March 4, 2003 -- GeneSoft Pharmaceuticals announced that the Anti-Infective Drugs Advisory Committee (AIDAC) of FDA)has recommended approval of Factive (gemifloxacin) for the treatment of two serious diseases that affect millions of Americans.
The Committee voted 18 in favor, with one abstention, to recommend approval of Factive in the treatment of mild to moderate community-acquired pneumonia. A majority of members voted in favor of using Factive in the treatment of acute exacerbation of chronic bronchitis.
The FDA will make the final decision on whether the drug will be approved.
"The positive recommendations and comments are a vote of confidence for Factive and are based on global clinical trials in nearly 10,000 people," said GeneSoft's CEO, David B. Singer. "In the coming weeks we will work with the FDA to help bring this important new medicine to the healthcare community," he added.
Factive was discovered by LG Life Sciences Ltd in Korea. Marketing rights for North America and Europe were licensed to GeneSoft in 2002.
Source: GeneSoft Pharmaceuticals
Posted: March 2003