Colestipol Hydrochloride Tablets 1 g
Marketed by:
IMPAX Laboratories Inc (Hayward, Calif)
Compared to:
Colestid (Pharmacia and Upjohn Co [Pfizer])
Indication:
October 26, 2006The FDA granted approval for
IMPAX Laboratories' Colestipol Hydrochloride Tablets.
The company also received first-to-file status and 180-
day market exclusivity for this product. The tablets are
indicated as adjunctive therapy to diet for the reduction
of elevated serum total and low-density lipoprotein
cholesterol (LDL-C) in patients with primary hypercholesterolemia
(elevated LDL-C) who do not respond
adequately to diet alone.
Dosage Form:
Tablets: 1 g
For More Information:
www.impaxlabs.com
Ondansetron Injection USP
Marketed by:
SICOR Pharmaceuticals Inc
(Irvine, Calif), a wholly owned
subsidiary of Teva
Pharmaceuticals
Compared to:
Zofran Injection (GlaxoSmithKline)
Indication:
November 22, 2006Teva Pharmaceuticals
announced the introduction and availability of
Ondansetron Injection USP. The product is AP-rated to
Zofran Injection. The product is indicated for the prevention
of nausea and vomiting associated with initial
and repeat courses of emetogenic cancer chemotherapy.
Ondansetron Injection is also indicated for the
prevention of postoperative nausea and/or vomiting.
Dosage Form:
2 mg/mL, 4 mg in single-dose glass vials, 2 mg/mL, 40
mg in multiple-dose glass vials, and 32 mg/50 mL in
flexible plastic containers.
For More Information:
www.sicor.com
800-729-9991
Glipizide ER Tablets
Marketed by:
Actavis
(Hafnarfjordur,
Iceland)
Compared to:
Glucotrol XL (Pfizer Inc)
Indication:
November 6, 2006Actavis announced the launch of
glipizide ER tablets in the United States. These tablets
are used as an adjunct to diet for the treatment of
type 2 diabetes, particularly in patients whose diabetes
cannot be controlled through diet alone.
Dosage Form:
Tablets: 2.5, 5, and 10 mg
For More Information:
www.actavis.com
Metronidazole Vaginal Gel, 0.75%
Marketed by:
QLT USA Inc (Fort Collins, Colo)
Compared to:
MetroGel-Vaginal
(3M Pharmaceuticals)
Indication:
November 1, 2006The FDA approved the first
generic version of metronidazole vaginal gel. The gel is
indicated to treat bacterial vaginosis, a condition in
women that is characterized by vaginal discharge and
results from an overgrowth of bacteria in the vagina.
QLT USA Inc is eligible for 180 days of generic drug
exclusivity.
Dosage Form:
Gel: 70-g tube
For More Information:
www.qltinc.com
Sulfacetamide Sodium Topical Suspension USP 10%
Marketed by:
Fougera, a division of Altana Inc
(Melville, NY)
Compared to:
Klaron (Dermik Laboratories)
Indication:
November 17, 2006Fougera, a
specialty pharmaceutical manufacturer,
announced that it received FDA approval to bring to
market the first generic Sulfacetamide Sodium Topical
Suspension USP 10%. This generic formulation is comparable
to Klaron, whose patent has expired. This
product is indicated for the topical treatment of acne.
Dosage Form:
118-mL bottle
For More Information:
www.fougera.com
800-645-9833