Generic Product News

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Fluconazole for Oral Suspension

Marketed by:
Teva Pharmaceuticals (North Wales, PA)

Compared to:
Diflucan (Pfizer Inc)

Indication:
September 22, 2008—Teva Pharmaceuticals announced the introduction and availability of Fluconazole for Oral Suspension. It is AB-rated and bioequivalent to Diflucan Oral Suspension. The product is indicated for the treatment of oropharyngeal and esophageal candidiasis, as well as cryptococcal meningitis. In open noncomparative studies of relatively small numbers of patients, fluconazole also was effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.

Dosage Form:
Oral suspension: 10 mg/mL and 40 mg/mL in 35-mL bottle sizes

For More Information:
www.tevausa.com
888-TEVA-USA (888-838-2872)



Fluoxetine Capsules USP

Marketed by:
Mylan Pharmaceuticals Inc (Pittsburgh, PA)

Compared to:
Sarafem Pulvules Capsules (Eli Lilly)

Indication:
November 18, 2008—Mylan Inc announced that its subsidiary, Mylan Pharmaceuticals Inc, received final FDA approval for its abbreviated new drug application for Fluoxetine Capsules USP, 10 and 20 mg. Fluoxetine capsules are indicated for the treatment of premenstrual dysphoric disorder (PMDD). The recommended dose of fluoxetine capsules for the treatment of PMDD is 20 mg/day given continuously (every day of the menstrual cycle) or intermittently (defined as starting a daily dose 14 days prior to the anticipated onset of menstruation through the first full day of menses and repeating with each new cycle). The dosing regimen should be determined by the physician based on individual patient characteristics.

Dosage Form:
Capsules: 10 and 20 mg

For More Information:
www.mylan.com
888-TEVA USA (888-838-2872)



Irinotecan Hydrochloride

Marketed by:
Barr Pharmaceuticals Inc (Montvale, NJ)

Compared to:
Camptosar Injection (Pfizer Inc)

Indication:
November 3, 2008—Barr Pharmaceuticals Inc announced that its subsidiary, PLIVA ? Lachema a.s., received approval from the FDA for Irinotecan Hydrochloride injection, 20 mg/mL, packaged in 40-mg/2-mL and 100-mg/5-mL vials. The product is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. Irinotecan Hydrochloride injection also is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.

Dosage Form:
20 mg/mL, packaged in 40-mg/2-mL and 100-mg/5-mL vials

For More Information:
www.barrlabs.com



Sumatriptan Succinate

Marketed by:
Dr. Reddy's Laboratories (Bridgewater, NJ)

Compared to:
Imitrex Tablets (GlaxoSmithKline)

Indication:
November 24, 2008—Dr. Reddy's Laboratories announced that it launched Sumatriptan Succinate tablets, the authorized generic version of GlaxoSmithKline's Imitrex. Dr. Reddy's is the first company to launch an authorized generic version of Imitrex tablets in the United States. Sumatriptan Succinate tablets are indicated for the acute treatment of migraine attacks in adults. The tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Safety and effectiveness of Sumatriptan Succinate tablets have not been established for cluster headache, which is present in an older, predominantly male population.

Dosage Form:
Tablets: 25, 50, and 100 mg

For More Information:
www.drreddys.com