BALTIMORE — The Food and Drug Administration has given Lupin Pharmaceuticals tentative approval to two of its products, the company said Wednesday.
Lupin announced the tentative approvals for armodafinil tablets in the 50-mg, 100-mg, 150-mg, 200-mg and 250-mg strengths and doxycycline capsules in the 40-mg strength. Tentative approval means that the drugs meet the FDA's conditions for approval, but can't be marketed yet due to patent or market exclusivity protection that has yet to expire.
Armodafinil tablets are a generic version of Cephalon's Nuvigil and are used to treat sleep disorders; Nuvigil had sales of about $420 million during the 12-month period that ended in March. Doxycycline capsules are a generic version of Galderma Labs' Oracea and are used to treat rosacea in adults; Oracea had sales of about $319 million during the same 12-month period.