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In April 2001 FDA issued a public health advisory on the safety of
the Terbinafine HCL tablets. This issue was based on the clinical
trials on 16 cases of liver failure and two liver transplant
patients. Lamisil if prescribed with some antidepressants and beta
blockers would have adverse effects.
However Novartis Pharmaceuticals has secured the approval of FDA (US
Food and Drug Administration) to the generic version of the
medication Lamisil. It is used in the treatment of onychomycosis.
The drug will be marketed as Terbinafine hydrochloride tablets. The
FDA has declared that Lamisil is a new treatment against ringworm of
the scalp in children aged four and above in September 2007.
Mylan Laboratories has also secured the approval of FDA for its
abbreviated new drug application for Terbinafine Hydrochloride pills
250mg. It is estimated that Terbinafine Hydrochloride tablets had a
US sales of around $ 685 million in March 2007. This indicates the
effectiveness of the drug in the treatment of fungal infections.
Glenmark a research based pharmaceutical company received a
tentative FDA approval for its oral tablet Terbinafine Hcl 250mg,
Glenmark is the manufacturer in India and it is marketed in US
through its subsidiary Glenmark Pharmaceuticals, Inc, USA.
FDA has also granted approval to Taro Pharmaceuticals to manufacture
the generic version of Lamisil cream which will be marketed as
terbinafine Hcl 1% cream which is approved to treat tinea pedis. The
treatment of fungal infections by terbinafine in the future is
expected to produce good results.
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