GlaxoSmithKline (GSK) has given up on a promising antibiotic for respiratory infections after the US Food and Drug Administration (FDA) expressed concerns about possible side effects.
The pharmaceutical group said today it was handing back rights to the drug called Factive to South Korea's LG Chem Investment.
Factive, also known by the generic name gemifloxacin, had been seen as a potentially important new medicine. But in December 2000, the FDA issued a "non-approvable letter" due to concerns about side effects.
Factive belongs to the quinolone class of antibiotics that have been associated with a range of side-effects, including liver toxicity and cardiovascular issues.
The decision to abandon the drug is the latest setback for Europe's biggest pharmaceutical group, which has suffered several product disappointments in the past two years that have left a gap in its late-stage pipeline.
A year earlier, the company was forced to withdraw bowel drug Lotronex on safety grounds, although there is a possibility it may be reapproved in the United States for limited use.