Lupin gets tentative approval from FDA for Armodafinil Tablets, Doxycycline Capsules

Aug 1 2013

elsPharma Major Lupin Limited announced that its U.S. subsidiary, Lupin Pharmaceuticals, Inc. (LPI) has received tentative approval for its Armodafinil Tablets, 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths as well as another tentative approval for its Doxycycline Capsules, 40 mg (30 mg Immediate-release and 10 mg Delayed-release) from the United States Food and Drugs Administration (FDA).

Lupin's Armodafinil Tablets are the AB-rated generic equivalent of Cephalon Inc's Nuvigil® tablets 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths. Armodafinil Tablet is indicated to improve wakefulness in adult patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), narcolepsy, or shift work disorder. Nuvigil® tablets, 50 mg, 100 mg, 150 mg, 200 mg and 250 mg had U.S sales of approximately USD420 million, for the twelve Rosaceamonths ending March, 2013 (IMS Health data).

Lupin's Doxycycline Capsules is the AB-rated generic equivalent of Galderma Laboratories Oracea® Capsules, 40 mg. Doxycycline Capsule is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. Oracea® Capsules had annual U.S sales of approximately USD 319 million for the twelve months ending March, 2013 (IMS Health data).