Pharmacy Times

Generic Product News



Calcium Acetate

Marketed by:
Sandoz Inc (Princeton, NJ)
Compared to:
PhosLo (Nabi Pharmaceuticals Inc)

Indication:
Sandoz recently introduced calcium acetate capsules, an authorized generic equivalent of PhosLo. Calcium acetate is a mineral indicated for the control of hyperphosphatemia in end-stage renal failure and does not promote aluminum absorption. The recommended initial dose of calcium acetate for the adult dialysis patient is 2 tablets with each meal. The dosage may be increased gradually to bring the serum phosphate value below 6 mg/dL, as long as hypercalcemia does not exist. Most patients require 3 to 4 tablets with each meal.

Dosage Form:
Capsules: 667 mg

For More Information:
www.us.sandoz.com


Fexofenadine HCl and Pseudoephedrine HCl Extended-release Tablets

Marketed by:
Teva Pharmaceuticals (North Wales, PA)
Compared to:
Allegra-D 12-Hour Extended-release Tablets (sanofi-aventis US)

Indication:
Teva Pharmaceuticals recently announced the introduction and availability of Fexofenadine HCl and Pseudoephedrine HCl Extended-release Tablets. Fexofenadine HCl and Pseudoephedrine HCl Extendedrelease Tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, itchy nose, palate, and/ or throat, itchy/watery/red eyes, and nasal congestion.

Dosage Form:
Tablets containing 60 mg fexofenadine hydrochloride for immediate release and 120 mg pseudoephedrine hydrochloride for extended release

For More Information:
www.tevausa.com
888-TEVA USA


Oral Transmucosal Fentanyl Citrate

Marketed by:
Covidien (St. Louis, MO)
Compared to:
Actiq (Cephalon Inc)

Indication:
Covidien recently announced that its subsidiary, Mallinckrodt Inc, received FDA approval of its abbreviated new drug application for Oral Transmucosal Fentanyl Citrate (CII). Covidien’s product is a generic alternative to Actiq. It is a solid formulation of fentanyl that resembles a lozenge on a handle. Oral transmucosal fentanyl citrate, a class II controlled substance, is an opioid analgesic indicated only for the management of breakthrough cancer pain in patients 16 years of age and older with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying, consistent cancer pain.

Dosage Form:
Solid drug matrix on a handle in 200, 400, 600, 800, 1200, and 1600 mcg

For More Information:
www.covidien.com


Topiramate Capsules (Sprinkle)

Marketed by:
Mylan Inc (Pittsburgh, PA)
Compared to:
Topamax (Ortho-McNeil)

Indication:
Mylan Inc announced that its subsidiary Mylan Pharmaceuticals Inc received approval for its abbreviated new drug application for Topiramate Capsules (Sprinkle), 15 and 25 mg. The capsules are the generic version of Ortho-McNeil’s anticonvulsant Topamax Sprinkle Capsules, 15 and 25 mg. Topiramate capsules are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures.

Dosage Form:
Capsules: 15 and 25 mg

For More Information:
www.mylan.com ■