FDAnews Drug Daily Bulletin

Generic-drug maker Mutual Pharmaceutical has asked the FDA to declare Skelaxin 800-mg tablets misbranded unless King Pharmaceuticals, the NDA holder, changes the product’s label to reflect that the muscle relaxant is a delayed-release formulation. Mutual submitted its petition after conducting three bioequivalence studies comparing Skelaxin (metaxalone) 800-mg tablets to immediate- and delayed-release dosage forms of metaxalone. Data from the studies indicate the immediate-release metaxalone isn’t extensively bioequivalent to Skelaxin. However, the delayed-release formulation is nearly bioequivalent, Mutual says in its petition.
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