www.fdanews.com/articles/61538-perrigo-s-generic-lamisil-granted-tentative-approval
PERRIGO'S GENERIC LAMISIL GRANTED TENTATIVE APPROVAL
August 8, 2006
Perrigo announced that its partner, InvaGen Pharmaceuticals, has received tentative approval from the FDA for its generic terbinafine hydrochloride tablets, 250 mg. Final approval is subject to the expiration of any applicable periods of patent protection for the reference tested drug, Novartis' Lamisil Tablets.
The listed patent will expire on Dec. 30, 2006, and is subject to an additional pediatric extension. Perrigo will market the products produced by InvaGen Pharmaceuticals.
Annual sales of Lamisil, which treats nail fungus, are approximately $750 million.