Lilly Receives Clearance To Market Dynabac in the United States.INDIANAPOLIS--(HealthWire)--Aug. 18, 1995--Eli Lilly and Company announced today it has received clearance from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. to market Dynabac(R), an advanced macrolide antibiotic macrolide antibiotic Infectious disease A broad-spectrum antibiotic–eg, erythromycin, produced by Streptomyces spp, that contains a lactone ring and inhibits protein synthesis in target bacteria. See Antibiotic resistance. that offers patients the convenience of once-daily dosing. Dynabac, whose generic name generic name n. 1. The official nonproprietary name of a drug, under which it is licensed and identified by the manufacturer. 2. is dirithromycin, is useful in treating certain bacteria that cause lower-respiratory-tract infections, pharyngitis pharyngitis Inflammation and infection (usually bacterial or viral) of the pharynx. Symptoms include pain (sore throat, worse on swallowing), redness, swollen lymph nodes, and fever. , tonsillitis tonsillitis Inflammatory infection of the tonsils, usually with hemolytic streptococci (see streptococcus) or viruses. The symptoms are sore throat, trouble in swallowing, fever, and enlarged lymph nodes on the neck. , and skin and skin structure infections. Dynabac is also the only one of the newer macrolides that has an approved indication for community-acquired pneumonia due to Legionella pneumophila. The most common side effects associated with Dynabac are gastrointestinal in nature. In clinical trials, Dynabac achieved a low rate of discontinuation due to these side effects. Lilly already markets dirithromycin under various trade names in several countries, including Austria, Belgium, the Philippines and Spain. The company is investigating potential partners to promote the drug in the United States. Eli Lilly and Company Eli Lilly and Company (NYSE: LLY) is a global pharmaceutical company and one of the world's largest corporations. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States. is a global research-based pharmaceutical corporation headquartered in Indianapolis, Ind., dedicated to creating and delivering superior health care solutions. By combining pharmaceutical innovations, existing pharmaceutical technology, disease prevention and management, and information technologies, Lilly provides customers worldwide with optimal clinical and economic outcomes. _______________________ Dynabac(R) (dirithromycin tablets, Lilly) CONTACT: Eli Lilly and Company, Indianapolis Amy Magan, 317/276-6337 |
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