Perrigo gets tentative approval to market generic Lamisil

By Elaine Rigoli

Tampa, Fla., Aug. 7 - Perrigo Co. announced that its partner, InvaGen Pharmaceuticals, Inc., has received tentative approval from the Food and Drug Administration for Terbinafine hydrochloride tablets, 250 mg, which Perrigo would market.

Final approval is subject to the expiration of any applicable periods of patent protection for the reference tested drug (Lamisil tablets 250 mg, Novartis Consumer Healthcare, Inc.) listed in the FDA's Orange Book, including pediatric exclusivity extension.

The listed patent will expire Dec. 30, subject to an additional pediatric extension.

Annual sales for the brand are about $750 million, according to a news release.

Based in Allegan, Mich., Perrigo is a health care supplier and manufacturer of pharmaceutical products.

InvaGen is a pharmaceutical company based in Hauppauge, N.Y.

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