SmithKline Albenza literature-based NDA for neurocysticercosis and hydatid disease clears FDA.
Executive Summary
SMITHKLINE ALBENZA FOR NEUROCYSTICERCOSIS AND HYDATID DISEASE APPROVAL by FDA June 11 was based on a literature review of the anthelmintic for the two orphan indications. FDA estimates that about 300 people in the U.S. are diagnosed with neurocysticercosis or hydatid disease each year. Albendazole has been marketed in other countries since 1982 and has been available in the U.S. under compassionate use INDs. Although not approved previously in the U.S., the drug has been cited in the medical literature as standard therapy. The NDA (20-666) for albendazole 200 mg tablets was submitted to the agency Dec. 8.
You may also be interested in...
GSK Albenza shortage
GlaxoSmithKline Albenza (albendazole) shortages due to "manufacturing issues not related to product quality" will be resolved by February, FDA drug shortages website reports Dec. 8. The anthelmintic is approved for neurocysticercosis and hydatid disease caused by tapeworm infections. The orphan indications are estimated to affect about 300 patients per year in the U.S. (1"The Pink Sheet" June 17, 1996, T&G-2)...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011