Content about rabeprazole sodium

February 20, 2014

Kremers Urban Pharmaceuticals announced the launch of rabeprazole sodium delayed-release tablets, which are used to treat gastroesophageal reflux disease in adults and adolescents.

PRINCETON, N.J. — Kremers Urban Pharmaceuticals, a subsidiary of UCB, announced the launch of rabeprazole sodium delayed-release tablets. The drug is used to treat gastroesophageal reflux disease in adults and adolescents, according to the FDA.

The product is the bioequivalent to Aciphex from Eisai. Kremers Urban rabeprazole sodium delayed-release tablets are available in 20-mg strength in both 30- and 90-count bottles.

November 11, 2013

Indian drug maker Lupin has launched its generic version of a drug used to treat gastroesophageal reflux disease, the company said Monday.

BALTIMORE — Indian drug maker Lupin has launched its generic version of a drug used to treat gastroesophageal reflux disease, the company said Monday.

Lupin announced the launch of rabeprazole sodium extended-release tablets in the 20-mg strength, a generic version of Eisai's Aciphex. The Food and Drug Administration approved generic versions of Aciphex made by six companies on Friday.

Aciphex had sales of about $864.3 million during the 12-month period that ended in June, according to IMS Health.

 

November 11, 2013

Mylan has launched its generic version of a drug used to treat gastroesophageal reflux disease, the U.S.-based generic drug maker said Monday.

PITTSBURGH — Mylan has launched its generic version of a drug used to treat gastroesophageal reflux disease, the U.S.-based generic drug maker said Monday.

Mylan announced the launch of rabeprazole sodium extended-release tablets in the 20-mg strength, a generic version of Eisai's Aciphex. The Food and Drug Administration approved generic versions of Aciphex made by six companies on Friday.

Aciphex had sales of about $830.1 million during the 12-month period that ended in September, according to IMS Health. 

November 8, 2013

The Food and Drug Administration has approved six generic versions of a drug used to treat gastroesophageal reflux disease, or GERD, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved six generic versions of a drug used to treat gastroesophageal reflux disease, or GERD, the agency said Friday.

The FDA announced the approval of the first generic versions of Eisai's Aciphex (rabeprazole sodium) delayed-release tablets for patients aged 12 and older. The generic products are made by Dr. Reddy's Labs, Kremers Urban Pharmaceuticals, Lupin Pharmaceuticals, Mylan Pharmaceuticals, Teva Pharmaceuticals USA and Torrent Pharmaceuticals.

February 18, 2011

SUPPLIER NEWS — Drug maker Valeant Pharmaceuticals International has acquired U.S. and Canadian rights to certain formulations of a GlaxoSmithKline drug used to treat cold sores. Valeant acquired the rights to nonophthalmic topical formulations of Zovirax (acyclovir) from GSK for $300 million through its Canadian subsidiary, Biovail Labs.



February 2, 2011

The Food and Drug Administration declined to approve a drug made by Eisai for treating gastroesophageal reflux disease, Eisai said Tuesday.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration declined to approve a drug made by Eisai for treating gastroesophageal reflux disease, Eisai said Tuesday.

The drug maker announced its receipt of a complete response letter from the agency for its application for rabeprazole sodium extended-release capsules, a proton-pump inhibitor for GERD. The FDA delivers a complete response letter when it has finished reviewing a regulatory approval application, but issues remain that preclude final approval of the drug.