Perrigo's generic terbinafine cleared in USA
US health care firm Perrigo says that its partner, InvaGen Pharmaceuticals, has received tentative approval from the Food and Drug Administration on its Abbreviated New Drug Application for terbinafine HCl tablets, 25mg (base).
Final approval is subject to the expiration of any applicable periods of patent protection for the reference tested drug (Novartis' Lamisil) listed in the FDA's Orange Book, including pediatric exclusivity extension. The listed patent will expire on December 30, 2006, subject to an additional pediatric extension. Perrigo will market the products produced under InvaGen Pharmaceuticals' ANDA.
Annual US sales for the brand are approximately $750.0 million, according to NDC data.
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