generic times product news

Author: Jim Middleton, BS, RPh

Cefdinir for Oral Suspension, 250 mg/5 mL

Marketed by:
Lupin Pharmaceuticals Inc (Baltimore, Md)

Compared to:
Omnicef (Abbott Laboratories)

Indication:
May 8, 2007 - Lupin Pharmaceuticals Inc announced that the FDA approved its abbreviated new drug application for Cefdinir for Oral Suspension, 250 mg/5 mL. With this approval, Lupin adds to its already existing line of Cefdinir products. Lupin was the first company to receive final FDA approval for the capsule form and the lower-strength suspension on May 19, 2006, and May 31, 2006, respectively. Cefdinir is indicated for the treatment of patients with mild-to-moderate infections caused by susceptible bacteria.

Dosage Form:
Oral suspension: 250 mg/5 mL

For More Information:
www.lupinpharmaceuticals.com
800-466-1450

Ciprofloxacin Extended-release Tablets

Marketed by:
Mylan Laboratories Inc (Pittsburgh, Pa)

Compared to:
Cipro XR Tablets (Bayer Pharmaceuticals Corp)

Indication:
March 26, 2007 - Mylan Laboratories announced the launch of its first-to-market generic product Ciprofloxacin Extended-release (ER) Tablets. The FDA approved Mylan Pharmaceuticals' abbreviated new drug application for 500- and 1000-mg strengths of Ciprofloxacin ER tablets on March 22, 2007. Ciprofloxacin ER tablets are indicated for the treatment of uncomplicated urinary tract infections (acute cystitis) caused by Escherichia coli, Proteus mirabilis, Enterococcus faecalis, or Staphylococcus saprophyticus; complicated urinary tract infections caused by E coli, Klebsiella pneumoniae, E faecalis, P mirabilis, or Pseudomonas aeruginosa; and acute uncomplicated pyelonephritis caused by E coli.

Dosage Form:
Tablets: 500 and 1000 mg

For More Information:
www.mylan.com

Nimodipine Capsules, 30 mg

Marketed by:
Barr Laboratories Inc, a subsidiary of Barr Pharmaceuticals Inc (Woodcliff Lake, NJ)

Compared to:
Nimotop Capsules, 30 mg (Bayer Pharmaceuticals Corp)

Indication:
May 2, 2007 - Barr Laboratories announced that it received final FDA approval to manufacture and market generic Nimodipine Capsules. Nimodipine, a calcium channel blocker, is indicated for the improvement of neurologic outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms, regardless of their postictus neurologic condition (ie, Hunt and Hess Grades I-V).

Dosage Form:
Capsules: 30 mg (not to be administered intravenously or by other parenteral routes)

For More Information:
www.barrlabs.com

Pravastatin Sodium

Tablets, 10, 20, 40, and 80 mg

Marketed by:
Ranbaxy Pharmaceuticals Inc, a wholly owned subsidiary of Ranbaxy Laboratories Ltd (Guragon, India)

Compared to:
Pravachol (Bristol-Myers Squibb Co)

Indication:
April 25, 2007 - Ranbaxy Pharmaceuticals announced that it received FDA approval to manufacture and market Pravastatin Sodium Tablets, 10, 20, 40, and 80 mg, with 180-day market exclusivity for the 80-mg strength. Pravastatin is indicated in the treatment or primary prevention of coronary events, such as in hypercholesterolemic patients without clinically evident coronary heart disease. It is also indicated to reduce the risk of myocardial infarction, reduce the risk of undergoing myocardial revascularization procedures, and reduce the risk of cardiovascular mortality with no increase in death from noncardiovascular causes. In addition, pravastatin is indicated for treatment in the secondary prevention of cardiovascular events.

Dosage Form:
Tablets: 10, 20, 40, and 80 mg

For More Information:
www.ranbaxyusa.com