Generic Product News

Author:



Lansoprazole Delayed-Release Capsules


Marketed by:
Sandoz Inc (Princeton, NJ)

Compared to:
Prevacid (Takeda Pharmaceuticals North America Inc)

Indication:
Sandoz recently announced the introduction of lansoprazole delayed-release capsules, an authorized generic equivalent of Prevacid. Lansoprazole, a proton pump inhibitor, is indicated for the treatment of active duodenal and gastric ulcers and the common symptoms of gastroesophageal reflux disease, including heartburn and erosive esophagitis. Lansoprazole delayed-release capsules offer the same efficacy and will be available in the same strengths as Prevacid.

Dosage Form:
Capsules: 15 and 30 mg

For More Information:
www.us.sandoz.com


Cefoxitin for Injection, USP

Marketed by:
Sagent Pharmaceuticals Inc (Schaumburg, IL)

Compared to:
Mefoxin (Merck & Co Inc)

Indication:
Sagent Pharmaceuticals recently announced the launch of an antibiotic of the cephalosporin family, which has activity against gram-positive and gram-negative bacteria—cefoxitin for injection, USP. Cefoxitin for injection, USP, is indicated for the treatment of serious infections caused by susceptible strains of designated microorganisms in these diseases: lower respiratory tract infections, including pneumonia and lung abscess, urinary tract infections, intra-abdominal infections, gynecologic infections, septicemia, bone and joint infections, and skin and skin structure infections.

Dosage Form:
Cefoxitin for injection, USP: Equivalent to 1 g of cefoxitin in a single-dose vial; equivalent to 2 g of cefoxitin in a single-dose vial

For More Information:
www.sagentpharma.com


Levetiracetam Tablets

Marketed by:
Mylan Inc (Pittsburgh, PA)

Compared to:
Keppra (UCB Inc)

Indication:
Mylan Inc announced that its subsidiary, Mylan Pharmaceuticals, received final approval from the FDA for its abbreviated new drug application for Levetiracetam Tablets, 1000 mg. Mylan has already received approval for and markets strengths of 250, 500, and 750 mg. Levetiracetam is indicated as adjunctive therapy in the treatment of partial-onset seizures in adults and children 4 years of age and older with epilepsy; as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy; and as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.

Dosage Form:
Tablets: 1000 mg (as well as 250, 500, and 750 mg)

For More Information:
www.mylan.com


Sotalol Hydrochloride Injection

Marketed by:
Bioniche Pharma (Lake Forest, IL) and Academic Pharmaceuticals Inc (Lake Bluff, IL)

Compared to:
Betapace (Bayer Schering Pharma)

Indication:
Bioniche Pharma and Academic Pharmaceuticals Inc announced that Sotalol Hydrochloride Injection for intravenous (IV) use is now available. Sotalol hydrochloride tablets are currently available under the brand name Betapace (Bayer Schering Pharma). Sotalol hydrochloride for IV use is an antiarrhythmic agent indicated for substitution for oral sotalol in patients who are unable to take sotalol orally (oral sotalol is indicated for maintenance of normal sinus rhythm in patients with a history of highly symptomatic atrial fibrillation/flutter, and treatment of documented life-threatening ventricular arrhythmias). Sotalol Hydrochloride for Injection has a black-box warning relating to life-threatening proarrhythmia.

Dosage Form:
150 mg sotalol hydrochloride in a 10-mL vial 15 mg/mL

For More Information:
www.bionichepharma.com ■