Lupin Pharmaceuticals has gained tentative FDA approvals for Armodafinil tablets, 50mg, 100mg, 150mg, 200mg and 250mg strengths in addition to Doxycycline capsules, 40mg (30mg immediate-release and 10mg delayed-release).
Armodafinil tablets are the AB-rated generic version of Cephalon's Nuvigil tablets 50mg, 100mg, 150mg, 200mg and 250mg indicated to improve wakefulness in adult patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), narcolepsy, or shift work disorder.
The US sales of Nuvigil tablets, 50mg, 100mg, 150mg, 200mg and 250mg were around $420m, for the twelve months ending March 2013, according to IMS Health data.
Lupin's Doxycycline Capsules, the AB-rated generic equivalent of Galderma Laboratories Oracea capsules, 40mg, is indicated to treat only inflammatory lesions (papules and pustules) of rosacea in adult patients.
The annual US sales for Oracea capsules were approximately $319m for the twelve months ending March 2013, as per IMS Health data.
