WebMD Medical News
Louise Chang, MD
July 2, 2007 -- The FDA today approved the first generic versions of
prescription Lamisil tablets to treat nail fungus infection and a generic
version of Lamisil cream to be sold as an over-the-counter athlete's foot
Lamisil is terbinafine hydrochloride. Its patent expired on June 30,
The FDA approved applications from multiple generic drugmakers for generic
versions of Lamisil tablets in 250-milligram formulations as a treatment for
nail fungus. Such infections occur when fungi invade a fingernail or toenail,
or the skin underneath the nail.
"This approval offers Americans additional alternatives when choosing
medications to treat nail fungus infections," says Gary J. Buehler, RPh, in
an FDA news release. Buehler directs the FDA's Office of Generic Drugs.
Lamisil tablets are usually taken for six to 12 weeks for nail infections.
Lamisil is not appropriate for people with liver and kidney disease. Patients
may be asked to get lab tests during that time to rule out rare liver and blood
side effects. More common side effects may include headache, diarrhea, and
Today's FDA announcement doesn't mention side effects specific to generic
versions of Lamisil.
The FDA also approved an application for a generic version of
over-the-counter Lamisil cream (terbinafine hydrochloride, 1%) to treat
athlete's foot, a skin disease caused by a fungus that usually occurs between
Companies making the approved generic versions of Lamisil include Amneal
Pharmaceuticals, Apotex, Aurobindo Pharma USA, Dr. Reddy’s Laboratories, Gedeon
Richter USA, Genpharm, Glenmark Pharmaceuticals, InvaGen Pharmaceuticals, Mylan
Pharmaceuticals, Orgenus Pharma, Roxane Laboratories, TEVA Pharmaceuticals USA,
Watson Laboratories, and Wockhardt USA.
The generic version of Lamisil cream is made by Taro Pharmaceuticals
SOURCES: News release, FDA. WebMD Drug Reference from First DataBank:
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