Recent FDA action (through December 2011) related to staccato loxapine, axitinib, mydicar, kalydeco, riboflavin ophthalmic solution, minocycline hydrochloride
Recommendations for approval
Fast-track designation
Priority review
• First-time generic approval
MInocycline hydrocholride extended-release tablets in 45-mg, 55-mg, 90-mg, and 135-mg strengths (equiv to Solodyn)
LUPIN PHARMACEUTICALS
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Cranbury, NJ 08512