Product News

Pharmacy Times, Volume 0,0

Acarbose Tablets

Marketed by:

Roxane Laboratories Inc (Columbus, OH)

Compared to:

PRECOSE (Bayer Pharmaceuticals Corp)

Indication:

May 7, 2008—RoxaneLaboratories Inc announcedthe approval of its abbreviatednew drug application forAcarbose Tablets, 25, 50, and100 mg. The product is available in bottles of 100 tabletsfor all strengths as well as unit-dose blisters for the50-mg strength. Roxane Laboratories' Acarbose tabletsare AB-rated to PRECOSE. Acarbose, as monotherapy,is indicated as an adjunct to diet to lower blood glucosein patients with type 2 diabetes mellitus whosehyperglycemia cannot be managed through diet alone.Acarbose also may be used in combination with a sulfonylureawhen diet plus either Acarbose or a sulfonylureado not result in adequate glycemic control. It alsomaybe used in combination with insulin or metformin.

Dosage Form:

Tablets: 25, 50, and 100 mg

For More Information:

www.roxane.com

800-962-8364

Belladonna & Opium Suppositories

Marketed by:

Paddock Laboratories Inc (Minneapolis, MN)

Indication:

February 27, 2008—Paddock Laboratoriesannounced the availabilityof Belladonna andOpium Suppositories CII.Belladonna and opium suppositories are used for reliefof moderate-to-severe pain associated with ureteralspasm not responsive to nonnarcotic analgesics and tospace intervals between injections of opiates. In adults,the recommended dosage is 1 belladonna and opiumsuppository rectally once or twice daily, not to exceed4 doses daily or as recommended by the physician.

Dosage Form:

Suppositories: 16.2 mg/30 mg and 16.2 mg/60 mg

For More Information:

www.paddocklabs.com

800-328-5113

Bethanechol Chloride Tablets

Marketed by:

Lannett Co Inc (Philadelphia, PA)

Compared to:

Urecholine Tablets (Odyssey Pharmaceuticals Inc)

Indication:

March 28, 2008—Lannett Co Incannounced that it received FDAapproval for its abbreviated newdrug application for bethanechol chloride tablets in 5-,10-, 25-, and 50-mg strengths. Bethanechol chloride isindicated for the treatment of acute postoperative andpostpartum nonobstructive (functional) urinary retentionand for neurogenic atony of the urinary bladderwith retention.

Dosage Form:

Tablets: 5, 10, 25, and 50 mg

For More Information:

www.lannett.com

Ropinirole Hydrochloride Tablets

Marketed by:

TEVA Pharmaceuticals (North Wales, PA)

Compared to:

Requip Tablets (GlaxoSmithKline)

Indication:

May 7, 2008—Teva Pharmaceuticals announced theintroduction and availability of Ropinirole HydrochlorideTablets. These tablets are AB-rated and bioequivalentto Requip Tablets. Ropinirole hydrochloride, an orallyadministered nonergoline dopamine agonist, is indicatedfor the treatment of moderate-to-severe primaryrestless legs syndrome (RLS). Key diagnostic criteriaare an urge to move the legs, usually accompanied orcaused by uncomfortable and unpleasant leg sensations,and symptoms begin or worsen during periodsof rest or inactivity, such as lying or sitting. Difficultyfalling asleep may frequently be associated with moderate-to-severe RLS.

Dosage Form:

Tablets: 0.25, 0.5, 1, 2, 3, and 4 mg

For More Information:

www.tevausa.com

888-TEVA USA (888-838-2872)