Generic Product News

Pharmacy Times, Volume 0, 0

Fluconazole for Oral Suspension

Marketed by:

Teva Pharmaceuticals (North Wales, PA)

Compared to:

Diflucan (Pfizer Inc)

Indication:

September 22, 2008—Teva Pharmaceuticalsannounced the introduction and availability ofFluconazole for Oral Suspension. It is AB-rated andbioequivalent to Diflucan Oral Suspension. The productis indicated for the treatment of oropharyngeal andesophageal candidiasis, as well as cryptococcal meningitis.In open noncomparative studies of relatively smallnumbers of patients, fluconazole also was effectivefor the treatment of Candida urinary tract infections,peritonitis, and systemic Candida infections includingcandidemia, 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 itssubsidiary, Mylan Pharmaceuticals Inc, received finalFDA approval for its abbreviated new drug applicationfor Fluoxetine Capsules USP, 10 and 20 mg. Fluoxetinecapsules are indicated for the treatment of premenstrualdysphoric disorder (PMDD). The recommendeddose of fluoxetine capsules for the treatment of PMDDis 20 mg/day given continuously (every day of themenstrual cycle) or intermittently (defined as startinga daily dose 14 days prior to the anticipated onset ofmenstruation through the first full day of menses andrepeating with each new cycle). The dosing regimenshould be determined by the physician based on individualpatient 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 Incannounced that its subsidiary, PLIVA ? Lachemaa.s., received approval from the FDA for IrinotecanHydrochloride injection, 20 mg/mL, packaged in40-mg/2-mL and 100-mg/5-mL vials. The productis indicated as a component of first-line therapy incombination with 5-fluorouracil and leucovorin forpatients with metastatic carcinoma of the colon orrectum. Irinotecan Hydrochloride injection also is indicatedfor patients with metastatic carcinoma of thecolon or rectum whose disease has recurred or progressedfollowing 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 Laboratoriesannounced that it launched Sumatriptan Succinatetablets, the authorized generic version ofGlaxoSmithKline's Imitrex. Dr. Reddy's is the first companyto launch an authorized generic version of Imitrextablets in the United States. Sumatriptan Succinate tabletsare indicated for the acute treatment of migraineattacks in adults. The tablets are not intended for theprophylactic therapy of migraine or for use in the managementof hemiplegic or basilar migraine. Safety andeffectiveness of Sumatriptan Succinate tablets havenot been established for cluster headache, which ispresent in an older, predominantly male population.

Dosage Form:

Tablets: 25, 50, and 100 mg

For More Information:

www.drreddys.com