Roxane Laboratories Inc (Columbus, OH)
PRECOSE (Bayer Pharmaceuticals Corp)
May 7, 2008—Roxane Laboratories Inc announced the approval of its abbreviated new drug application for Acarbose Tablets, 25, 50, and 100 mg. The product is available in bottles of 100 tablets for all strengths as well as unit-dose blisters for the 50-mg strength. Roxane Laboratories' Acarbose tablets are AB-rated to PRECOSE. Acarbose, as monotherapy, is indicated as an adjunct to diet to lower blood glucose in patients with type 2 diabetes mellitus whose hyperglycemia cannot be managed through diet alone. Acarbose also may be used in combination with a sulfonylurea when diet plus either Acarbose or a sulfonylurea do not result in adequate glycemic control. It also may be used in combination with insulin or metformin.
Tablets: 25, 50, and 100 mg
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Paddock Laboratories Inc (Minneapolis, MN)
February 27, 2008—Paddock Laboratories announced the availability of Belladonna and Opium Suppositories CII. Belladonna and opium suppositories are used for relief of moderate-to-severe pain associated with ureteral spasm not responsive to nonnarcotic analgesics and to space intervals between injections of opiates. In adults, the recommended dosage is 1 belladonna and opium suppository rectally once or twice daily, not to exceed 4 doses daily or as recommended by the physician.
Lannett Co Inc (Philadelphia, PA)
Urecholine Tablets (Odyssey Pharmaceuticals Inc)
March 28, 2008—Lannett Co Inc announced that it received FDA approval for its abbreviated new drug application for bethanechol chloride tablets in 5-, 10-, 25-, and 50-mg strengths. Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.
TEVA Pharmaceuticals (North Wales, PA)
Requip Tablets (GlaxoSmithKline)
May 7, 2008—Teva Pharmaceuticals announced the introduction and availability of Ropinirole Hydrochloride Tablets. These tablets are AB-rated and bioequivalent to Requip Tablets. Ropinirole hydrochloride, an orally administered nonergoline dopamine agonist, is indicated for the treatment of moderate-to-severe primary restless legs syndrome (RLS). Key diagnostic criteria are an urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant leg sensations, and symptoms begin or worsen during periods of rest or inactivity, such as lying or sitting. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.
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