PRODUCT news
Amoxicillin and Clavulanate Potassium for Oral Suspension
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Marketed by:
Sandoz Inc (Princeton, NJ)
Compared to:
Augmentin ES-600 (GlaxoSmithKline)
Indication:
October 1, 2007—Sandoz Inc introduced an extension
of its line of amoxicillin and clavulanate potassium for
oral suspension. This newest addition is being marketed
in 600-mg/42.9-mg-per-5-mL strength. In addition,
the company markets amoxicillin and clavulanate
potassium in tablets and in chewable tablets.
Amoxicillin and clavulanate potassium is used to treat
bacterial infections.
Dosage Form:
Oral suspension: 600 mg/42.9 mg per 5 mL,
200 mg/28.5 mg per 5 mL, and 400 mg/57 mg per
5 mL; Tablets: 250 mg/125 mg, 500 mg/125 mg, and
875 mg/125 mg; Chewable tablets: 200 mg/28.5 mg
and 400 mg/57 mg
For More Information:
www.us.sandoz.com
Ciclopirox Topical Solution, 8% (Nail Lacquer)
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Marketed by:
Teva Pharmaceuticals (North Wales, Pa)
Compared to:
Penlac Nail Lacquer (Aventis Pharmaceuticals Inc)
Indication:
September 19, 2007—Teva Pharmaceuticals
announced the introduction and availability of
Ciclopirox Topical Solution, 8% (Nail Lacquer). As a
component of a comprehensive management program,
this product is indicated as topical treatment in
immunocompetent patients with mild-to-moderate
onychomycosis of the fingernails and toenails without
lunula involvement, due to Trichophyton rubrum. The
comprehensive management program also includes
removal of the unattached, infected nails as frequently
as monthly by a health care professional who has
special competence in the diagnosis and treatment of
nail disorders, including minor nail procedures.
Dosage Form:
6.6-mL glass bottles
For More Information:
www.tevausa.com
Hydrocodone Bitartrate and Acetaminophen Tablets USP
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Marketed by:
Ranbaxy Pharmaceuticals Inc (Jacksonville, Fla)
Compared to:
Vicodin ES Tablets (Abbott Laboratories); Norco Tablets (Watson Pharmaceuticals Inc); Lortab Tablets (UCB Inc)
Indication:
August 20, 2007—Ranbaxy Pharmaceuticals Inc, a
wholly owned subsidiary of Ranbaxy Laboratories Ltd
(RLL), announced that RLL received FDA approval to
manufacture and market Hydrocodone Bitartrate and
Acetaminophen Tablets USP, 7.5-mg/750-mg, 10-
mg/500-mg, 5-mg/500-mg, and 10-mg/325-mg
strengths. The Office of Generic Drugs, US FDA, has
determined the Ranbaxy formulations to be bioequivalent
and to have the same therapeutic effect as that
of the reference listed drugs as follows: 10-mg/325-
mg Norco Tablets from Watson Pharmaceuticals Inc;
5-mg/500-mg Vicodin Tablets and 7.5-mg/750-mg
Vicodin ES Tablets, both from Abbott Laboratories; and
10-mg/500-mg Lortab Tablets from UCB Inc. These
tablets are indicated for the relief of moderate-tomoderately
severe pain.
Dosage Form:
Tablets: 7.5 mg/750 mg, 10 mg/500 mg, 5 mg/500 mg,
and 10 mg/325 mg
For More Information:
www.ranbaxyusa.com
Quinapril Tablets
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Marketed by:
Teva Pharmaceuticals (North Wales, Pa)
Compared to:
Accupril Tablets (Warner-Lambert Co)
Indication:
October 3, 2007—Teva Pharmaceuticals announced
the introduction and availability of Quinapril Tablets
USP. They are indicated for the treatment of hypertension
and may be used alone or in combination with
thiazide diuretics. Black patients receiving
angiotensin-converting enzyme (ACE) inhibitor
monotherapy have been reported to have a higher
incidence of angioedema, compared with nonblacks.
It also should be noted that, in controlled clinical trials,
ACE inhibitors have an effect on blood pressure that
is less in black patients than in nonblacks.
Dosage Form:
Tablets: 5, 10, 20, and 40 mg
For More Information:
www.tevausa.com
