Product News

Pharmacy Times, Volume 0, 0

Alendronate Sodium Tablets

Marketed by:

Sun Pharmaceutical Industries (Mumbai, India)

Compared to:

Fosamax (Merck & Co)

Indication:

September 12, 2008—SunPharmaceutical Industries Ltdannounced that the FDA grantedfinal approval for the company's abbreviated newdrug application for Alendronate Sodium Tablets.Alendronate Sodium Tablets are indicated for thetreatment and prevention of osteoporosis in postmenopausalwomen, to increase bone mass in menwith osteoporosis, in the treatment of glucocorticoidinducedosteoporosis, and Paget's disease of thebone in men and women.

Dosage Form:

Tablets: 5, 10, 35, and 70 mg (base)

For More Information:

www.sunpharma.com

Azithromycin for Oral Suspension USP

Marketed by:

Teva Pharmaceuticals (North Wales, PA)

Compared to:

Zithromax for Oral Suspension (Pfizer Inc)

Indication:

September 22, 2008—Teva Pharmaceuticalsannounced the introduction and availability ofAzithromycin for Oral Suspension USP. It is AB-ratedand bioequivalent to Zithromax for Oral Suspension.The product is indicated for the treatment of patientswith mild-to-moderate infections caused by susceptiblestrains of the designated microorganismsin conditions such as acute bacterial exacerbationsof chronic obstructive pulmonary disease due toHaemophilus influenzae, Moraxella catarrhalis, orStreptococcus pneumoniae.

Dosage Form:

Oral suspension: 100 mg/5 mL in 15-mL bottles and200 mg/5 mL in 15-, 22.5-, and 30-mL bottles

For More Information:

www.tevausa.com

888-TEVA USA (888-838-2872)

Calcium Acetate Capsules

Marketed by:

Roxane Laboratories Inc (Columbus, OH)

Compared to:

PhosLo capsules (Fresenius Medical Care)

Indication:

October 15, 2008—Roxane Laboratories Incannounced the FDA approval of its abbreviated newdrug application for Calcium Acetate Capsules, 667mg. Calcium Acetate Capsules are indicated for thecontrol of hyperphosphatemia in end-stage renalfailure and do not promote aluminum absorption.The product is contraindicated in patients with hypercalcemia.The recommended initial dose of calciumacetate capsules for the adult dialysis patient is 2capsules with each meal.

Dosage Form:

Capsules: 667 mg

For More Information:

www.roxane.com

800-962-8364

Carbidopa and Levodopa Orally Disintegrating Tablets

Marketed by:

Mylan Inc (Pittsburgh, PA)

Compared to:

Parcopa ODT (Schwarz Pharma)

Indication:

September 22, 2008—Mylan Inc announced that itssubsidiary, Mylan Pharmaceuticals Inc, received finalFDA approval for its abbreviated new drug applicationfor Carbidopa and Levodopa Orally DisintegratingTablets, 10 mg/100 mg, 25 mg/100 mg, and 25mg/250 mg. These tablets are in the category of anantiparkinsonian agent and are indicated for the treatmentof idiopathic Parkinson's disease. Carbidopaand Levodopa Orally Disintegrating Tablets are administeredorally and rapidly disintegrate on the tongueand do not require water to aid dissolution or swallowing.

Dosage Form:

Tablets: 10 mg/100 mg, 25 mg/100 mg, and25 mg/250 mg

For More Information:

www.mylan.com