Generic Product News

Published Online: Wednesday, February 9, 2011
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Amlodipine Besylate/Benazepril Capsules

Marketed by:

Sandoz (Princeton, NJ)

Compared to:
Lotrel (Novartis)

Indication:
Sandoz introduced 2 higher dosage strengths of amlodipine besylate/benazepril capsules, the authorized generic equivalent of Lotrel, which is currently marketed by Novartis. The new dosage strengths, 5/40 and 10/40 mg, complement Sandoz’s existing line of amlodipine besylate/benazepril capsules in strengths of 2.5/10, 5/10, 5/20, and 10/20 mg. The capsules contain a combination of the angiotension converting enzyme (ACE) inhibitor benazepril hydrochloride and the calcium channel blocker amlodipine besylate, and are indicated for the treatment of hypertension in patients whose blood pressure is not controlled by monotherapy with either agent. Like other ACE inhibitors, amlodipine besylate/benazepril capsules carry a black box warning stating that if pregnancy is detected, they should be discontinued as soon as possible.

Dosage Form:
Capsules: 2.5/10, 5/10, 5/20, 10/20, 5/40, and 10/40 mg

For More Information:
www.us.sandoz.com
609-627-8500 70 n 02.11


Propafenone Extended Release Capsules

Marketed by:

Par Pharmaceutical Companies (Spring Valley, NY)

Compared to:
Rythmol SR (GlaxoSmithKline)

Indication:
The FDA approved Par Pharmaceutical’s propafenone extended release capsules, the generic version of GlaxoSmithKline’s Rythmol SR. Propafenone extended release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation in patients without structural heart disease. Propafenone is a Class 1C antiarrhythmic drug with local anesthetic effects and a direct stabilizing action on myocardial membranes. Propafenone extended release capsules are contraindicated in the presence of congestive heart failure (eg, sick sinus node syndrome, atrioventricular block) in the absence of an artificial pacemaker, bradycardia, marked hypotension, bronchospastic disorders, electrolyte imbalance, or hypersensitivity to the drug.

Dosage Form:
Capsules: 225, 325, and 425 mg

For More Information:
www.parpharm.com
201-802-400



Zafirlukast Tablets

Marketed by:

Dr. Reddy’s Laboratories (Hyderabad, India)

Compared to:
Accolate (AstraZeneca)

Indication:
Dr. Reddy’s Laboratories announced the launch of zafirlukast tablets, a bioequivalent generic version of AstraZeneca’s Accolate. Zafirlukast tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years and older. Zafirlukast is not a bronchodilator, and should not be used to treat acute episodes of asthma. Pharmacists should be aware that coadministration of zafirlukast with warfarin results in a clinically significant increase in prothrombin time. Patients taking oral warfarin anticoagulant therapy and zafirlukast should have their prothrombin times monitored closely and anticoagulant dose adjusted accordingly.

Dosage Form:
Tablets: 10 and 20 mg

For More Information:
www.drreddys.com


Acarbose Tablets

Marketed by:

Mylan (Pittsburgh, PA)

Compared to:
Precose (Bayer)

Indication:
Mylan announced that its subsidiary, Mylan Pharmaceuticals, received FDA approval for acarbose tablets, the generic version of Bayer’s Precose. Acarbose is an oral alphaglucosidase inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dosage of acarbose tablets must be individualized, and should not exceed the maximum recommended dose of 100 mg. Acarbose tablets should be taken 3 times daily with the first bite of each main meal. The therapeutic goal should be to decrease postprandial plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose. Gastrointestinal symptoms are the most common reactions to acarbose, and typically subside over time.

Dosage Form:
Tablets: 25, 50, and 100 mg

For More Information:
www.mylan.com


Indomethacin Extended- Release Capsules

Marketed by:

Paddock Laboratories (Minneapolis, MN)

Compared to:
Indocin (Merck)

Indication:
Paddock introduced its indomethacin extendedrelease capsules, a nonsteroidal anti-inflammatory drug (NSAID) used to treat a variety of arthritic conditions. Paddock’s product is the generic equivalent to Merck’s Indocin, and is indicated for the treatment of moderate to severe pain, swelling, and stiffness caused by rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis, as well as shoulder pain caused by acute bursitis and tendinitis. Indomethacin is not recommended for the treatment of acute gouty arthritis, and should not be taken in conjunction with aspirin or other salicylates. Because NSAIDs can cause ulcers and bleeding, patients should be urged to report any serious gastrointestinal signs or symptoms to a health care provider.

Dosage Form:
Capsules: 75 mg

For More Information:
www.paddocklabs.com
800-328-5113


Fentanyl Buccal Tablets USP

Marketed by:

Watson Pharmaceuticals (Morristown, NJ)

Compared to:
Fentora (Cephalon)

Indication:
Watson Laboratories, a subsidiary of Watson Pharmaceuticals, announced the FDA approval of its Abbreviated New Drug Application for fentanyl buccal tablets. Watson’s product is equivalent to Fentora, an opioid analgesic marketed by Cephalon. Fentanyl buccal tablets are indicated to treat breakthrough pain in adult patients with cancer who are already receiving and are tolerant to around-the-clock opioid therapy for persistent cancer pain. The tablets are designed to disintegrate within 14 to 25 minutes when placed above a rear molar, between the upper cheek and gum. Patients should not split, suck, chew, or swallow the tablets, and should alternate sides of the mouth when taking subsequent doses of the drug.

Dosage Form:
Tablets: 0.1, 0.2, 0.4, 0.6, and 0.8 mg

For More Information:
www.watson.com
973-355-8300


Pantoprazole Delayed Release Tablets

Marketed by:

Wockhardt (Mumbai, India)

Compared to:
Protonix (Pfizer/Wyeth Pharmaceuticals)

Indication:
Wockhardt announced the FDA approval and launch of pantoprazole delayed release tablets, a generic version of Protonix, which is currently manufactured by Pfizer and Wyeth Pharmaceuticals. Pantoprazole is a proton pump inhibitor indicated for the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD). It is also indicated to maintain healing of erosive esophagitis, to reduce relapse rates of heartburn symptoms in patients with GERD, and to treat pathological hypersecretory conditions, including Zollinger-Ellison syndrome. For shortterm treatment, the recommended dosing schedule is 40 mg, taken once daily for up to 8 weeks. If adult patients have not healed within 8 weeks, an additional 8-week treatment course may be considered.

Dosage Form:
Tablets: 20 and 40 mg

For More Information:
www.wockhardt.com


Doxycycline Hyclate Delayed Release Tablets

Marketed by:

Global Pharmaceuticals,a division of Impax Laboratories (Hayward, CA)

Compared to:
Doryx (Warner Chilcott)

Indication:
Impax Laboratories announced the FDA approval of doxycycline hyclate delayed release tablets, a generic version of Warner Chilcott’s Doryx. The product will be launched through Global Pharmaceuticals, Impax’s generic division. Doxycycline is a tetracycline-class antibacterial indicated for rickettsial infections; sexually transmitted infections; respiratory tract infections; specific bacterial infections; ophthalmic infections; anthrax, including inhalational anthrax (postexposure); alternative treatment for selected infections when penicillin is contraindicated; adjunctive therapy in acute intestinal amebiasis and severe acne; and prevention of malaria. Patients taking doxycycline tablets should be advised to drink plenty of fluids with each dose and avoid excessive exposure to sunlight.

Dosage Form:
Tablets: 75 and 100 mg

For More Information:
www.impaxlabs.com
510-476-2000



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