Fluconazole for Oral Suspension
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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
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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
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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
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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