Acarbose Tablets
Marketed by:
Roxane Laboratories Inc (Columbus, OH)
Compared to:
PRECOSE (Bayer Pharmaceuticals Corp)
Indication:
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.
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 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.
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 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.
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 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.
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)
