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The new products include branded drugs, new formulations, new indications, and new dosing, along with OTCs and home health and beauty items.
NEW DOSAGE STRENGTHS
Cephalon Inc., Frazer, Pa., (610) 344-0200, has been granted approval for a 30-mg strength of Amrix (cyclobenzaprine hydrochloride extended-release capsules). Amrix is a once-daily skeletal muscle relaxant for the relief of muscle spasm associated with acute and painful musculoskeletal conditions. It was already available in 15 mg.
Caraco Pharmaceutical Laboratories has also been given the nod to market methimazole tablets, USP, in strengths of 5 mg and 10 mg. The drug, indicated for the treatment of hyperthyroidism, provides a therapeutic equivalent to the FDA's reference listed drug in the Orange Book.