Product News

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Clotrimazole Cream USP 1%

Marketed by:
Fougera, a division of Nycomed US Inc (Melville, NY)

Compared to::
Clotrimazole, Reference Listed Drug (Taro Pharmaceutical Industries Ltd)

Indication:
September 12, 2008—Fougera announced the FDA approval of its Clotrimazole Cream USP 1%. The generic formulation compares to Taro's Reference Listed Drug and is available in 3 sizes: 15-, 30-, and 45-g tubes. Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infection caused by various species of pathogenic dermatophytes, yeasts, and Malassezia furfur. It is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur.

Dosage Form:
1% cream: 15-, 30-, and 45-g tubes

For More Information:
800-645-9833
www.fougera.com



Doxycycline for Oral Suspension USP

Marketed by:
Teva Pharmaceuticals (North Wales, PA)

Compared to::
Vibramycin for Oral Suspension (Pfizer Inc)

Indication:
August 12, 2008—Teva Pharmaceuticals announced the introduction and availability of Doxycycline for Oral Suspension USP. Doxycycline for Oral Suspension USP is indicated for the treatment of many infections, including Rocky Mountain spotted fever, typhus fever and the typhus group, lymphogranuloma venereum caused by Chlamydia trachomatis, and others. To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline for Oral Suspension USP and other antibacterial drugs, the product should only be used to treat or prevent infections that are proved or strongly suspected to be caused by susceptible bacteria.

Dosage Form:
25-mg/5-mL strength in a 60-mL bottle

For More Information:
www.tevausa.com



Eplerenone Tablets

Marketed by:
Greenstone LLC (Peapack, NJ)

Compared to::
Inspra (Pfizer Inc)

Indication:
October 2008—Greenstone LLC, the generic pharmaceutical subsidiary of Pfizer Inc, has introduced Eplerenone tablets. Eplerenone tablets are the same size, shape, and color as the referenced brand tablets and will be the only authorized generic available; they are available in both 25- and 50-mg tablets. Both strengths are available in 30- and 90-count bottles, with the 25 mg also available in 100-count blister packaging. Eplerenone tablets are indicated for improving survival of stable patients with left ventricular systolic dysfunction and congestive heart failure after an acute myocardial infarction, as well as for hypertension, alone or combined with other agents.

Dosage Form:
Tablets: 25 and 50 mg

For More Information:
800-438-1985
www.greenstonellc.com



Risperidone Tablets

Marketed by:
Mylan Inc (Pittsburgh, PA)

Compared to::
Risperdal (Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals Inc)

Indication:
September 16, 2008—Mylan Inc announced that its subsidiary Mylan Pharmaceuticals Inc received final approval from the FDA for its Abbreviated New Drug Application for Risperidone Tablets USP, 0.25, 0.5, 1, 2, 3, and 4 mg. These tablets are used to treat schizophrenia and bipolar disorder. Risperidone is indicated for the treatment of schizophrenia in adults and adolescents aged 13 to 17 years; alone or in combination with lithium or valproate for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder in adults, and alone in children and adolescents aged 10 to 17 years; and treatment of irritability associated with autistic disorder in children and adolescents aged 5 to 16 years.

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

For More Information:
www.mylan.com