/publications/issue/2009/2009-04/2009-04-10214

Generic Product News

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Omeprazole Delayed-Release Capsules

Marketed by:
Teva Pharmaceuticals (North Wales, PA)

Compared to:
Prilosec (AstraZeneca)

Indication:
Teva Pharmaceuticals announced the launch of Omeprazole Delayed-Release Capsules, 40 mg. It is AB-rated and bioequivalent to AstraZeneca’s Prilosec Delayed-Release Capsules. The new 40-mg strength is available in 100- and 1000-count bottles. The product is a proton pump inhibitor indicated for the treatment of duodenal and gastric ulcers in adults, gastroesophageal reflux disease in pediatric patients and adults, maintenance and healing of erosive esophagitis in pediatric patients and adults, and treatment of pathologic hypersecretory conditions in adults.

Dosage Form:
Capsules: 10, 20, and 40 mg

For More Information:
www.tevausa.com
888-TEVA-USA (888-838-2872)



Lamotrigine Tablets and Lamictal CD Tablets

Marketed by:
Mylan Pharmaceuticals Inc (Pittsburgh, PA)

Compared to:
Lamictal and Lamictal CD (GlaxoSmithKline)

Indication:
Mylan Pharmaceuticals Inc and Genpharm ULC, both subsidiaries of Mylan Inc, received FDA approval for their abbreviated new drug applications (ANDAs) for Lamotrigine Tablets. Genpharm also received FDA approval for its ANDA for Lamotrigine Tablets Chewable Dispersible (CD). Lamotrigine Tablets were approved for 25-, 100-, 150-, and 200-mg strengths. Lamotrigine CD gained approval for 5- and 25-mg strengths. These products are indicated for the treatment of epilepsy and for maintenance treatment of bipolar I disorder.

Dosage Form:
Tablets: 25, 100, 150, and 200 mg
Chewable Dispersible: 5 and 25 mg

For More Information:
www.mylan.com



Sumatriptan Succinate Tablets


Marketed by:
Ranbaxy Pharmaceuticals Inc (Jacksonville, FL)

Compared to:
Imitrex Tablets (GlaxoSmithKline)

Indication:
Ranbaxy Pharmaceuticals Inc received final FDA approval for its abbreviated new drug application for sumatriptan succinate tablets, 100 mg. Sumatriptan succinate tablets are indicated for the acute treatment of migraine attacks with or without aura in adults. They are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Safety and effectiveness of sumatriptan succinate tablets have not been established for cluster headache.

Dosage Form:
Tablets: 100 mg

For More Information:
1-888-RANBAXY



Divalproex Sodium Capsules

Marketed by:
Zydus Pharmaceuticals, Inc (Princeton, NJ)

Compared to:
Depakote (Abbott Laboratories)

Indication:
Zydus announced FDA approval for its abbreviated new drug application for Divalproex Sodium Capsules. The product is the generic version of Abbott Laboratories’ Depakote. Divalproex Sodium Capsules are indicated as a monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures. The product also is indicated as an adjunctive therapy in patients with multiple seizure types that include absence seizures.

Dosage Form:
Capsules: 125 mg

For More Information:
www.zydususa.com