Generic Product News

Pharmacy Times, Volume 0, 0

Omeprazole Delayed-Release Capsules

Marketed by:

Teva Pharmaceuticals(North Wales, PA)

Compared to:

Prilosec (AstraZeneca)

Indication:

Teva Pharmaceuticalsannounced the launch ofOmeprazole Delayed-Release Capsules, 40 mg. It isAB-rated and bioequivalent to AstraZeneca’s PrilosecDelayed-Release Capsules. The new 40-mg strength is available in 100- and 1000-count bottles.The product is a proton pump inhibitor indicatedfor the treatment of duodenal andgastric ulcers in adults, gastroesophagealreflux disease in pediatric patients andadults, maintenance and healing of erosiveesophagitis in pediatric patients and adults,and treatment of pathologic hypersecretoryconditions 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 GenpharmULC, both subsidiaries of Mylan Inc, receivedFDA approval for their abbreviated new drugapplications (ANDAs) for Lamotrigine Tablets. Genpharmalso received FDA approval for its ANDA for Lamotrigine Tablets Chewable Dispersible (CD). LamotrigineTablets were approved for 25-, 100-, 150-, and 200-mgstrengths. Lamotrigine CD gained approval for 5- and25-mg strengths. These products are indicated for thetreatment of epilepsy and for maintenance treatment ofbipolar 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 FDAapproval for its abbreviated new drug application forsumatriptan succinate tablets, 100 mg. Sumatriptansuccinate tablets are indicated for the acute treatmentof migraine attacks with or without aura in adults.They are not intended for the prophylactic therapy ofmigraine or for use in the management of hemiplegicor basilar migraine. Safety and effectiveness of sumatriptansuccinate tablets have not been established forcluster 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 (AbbottLaboratories)

Indication:

Zydus announced FDA approval for its abbreviated newdrug application for Divalproex Sodium Capsules. Theproduct is the generic version of Abbott Laboratories’Depakote. Divalproex Sodium Capsules are indicated asa monotherapy and adjunctive therapy of complex partialseizures and simple and complex absence seizures.The product also is indicated as an adjunctive therapyin patients with multiple seizure types that includeabsence seizures.

Dosage Form:

Capsules: 125 mg

For More Information:

www.zydususa.com