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Review of new branded drugs, generics, OTCs, home health products, health and beauty aids, etc.
Coria Laboratories, Fort Worth, (817) 302-3800, has received FDA approval for Atralin (tretinoin) Gel, 0.05%. The product is approved as a topical treatment for acne vulgaris.
Anesiva Inc., South San Francisco, (650) 624-9600, has a newly approved powder intradermal injection system. Zingo (lidocaine hydrochloride monohydrate) is a single-use needle-free system that provides rapid-acting topical analgesia to reduce the pain of IV insertions or blood draws, in children ages three to 18.
Indevus Pharmaceuticals, Lexington, Mass., (781) 861-8444, has approval for an extended-release formulation of its muscarinic receptor-antagonist. Sanctura XR (trospium chloride extended-release capsules) is indicated for once-daily treatment of overactive bladder with symptoms that include urge urinary incontinence, urgency, and urinary frequency.
NEW DOSAGE STRENGTHS
Multiple strengths of hydrocodone bitartrate and acetaminophen tablets USP have been approved for Ranbaxy Pharmaceuticals, Princeton, N.J., (609) 720-9200. The drug is indicated for the relief of moderate to moderately severe pain. The varying strengths are bioequivalent to branded drugs as follows: in 10 mg/325 mg, to Watson's Norco Tablets; in 5 mg/500 mg, to Vicodin Tablets and 7.5 mg/750 mg, to Vicodin ES Tablets, both from Abbott Laboratories; and in 10 mg/500 mg, to UCB's Lortab Tablets.