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Lupin receives tentative approval for generic sleeping, rosacea drugs
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.