Perrigo seeks approval for generic Zegerid OTC, Schering-Plough files suit
ALLEGAN, Mich. Perrigo has filed for regulatory approval of a generic version of an over-the-counter medication for frequent heartburn, prompting a lawsuit from the branded version’s manufacturer.
The company announced Friday that it had filed for approval for omeprazole and sodium bicarbonate in the 20 mg/1,100 mg strength. The medication is a generic version of Zegerid OTC, made by Schering-Plough HealthCare, a subsidiary of Merck.
Schering-Plough filed a lawsuit Monday alleging patent infringement in the U.S. District Court for the District of New Jersey to prevent Perrigo’s commercialization of the product.
Zegerid had sales of around $60 million during the 12-month period ended in the “most recent month,” according to SymphonyIRI Group.
FDA to allow GSK’s Avandia, with restrictions
SILVER SPRING, Md. The Food and Drug Administration has moved to significantly restrict access to a controversial diabetes drug made by GlaxoSmithKline.
The agency said Thursday that it would restrict access to the Type 2 diabetes medication Avandia (rosiglitazone) in response to clinical study data suggesting that its use can increase the risk of heart attacks and strokes.
The FDA is requiring GSK to develop a restricted access program for the drug under a risk evaluation and mitigation strategy. Under the REMS, Avandia will be available to patients only if they cannot control their glucose levels with Actos (pioglitazone), a drug made by Takeda in the same class as Avandia.
“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” FDA commissioner Margaret Hamburg said. “We are seeking to strike the right balance to support clinical care.”
Actos has some issues of its own. Last week, the FDA said it would conduct a safety review of the drug after receiving data from a study conducted by Takeda suggesting that some patients taking the drug for the longest periods of time and in the highest dosage could be at risk for bladder cancer. The study did not show an overall association between taking Actos and the risk of bladder cancer, and the FDA said it had not concluded that a risk existed.
Abbott, Reata ink deal for chronic kidney disease treatment
ABBOTT PARK, Ill. Drug makers Abbott and Reata Pharmaceuticals have signed an agreement concerning a drug for chronic kidney disease.
The two companies said Thursday that they would develop and commercialize bardoxolone methyl, currently in mid-stage clinical trials.
Under the agreement, Abbott will have exclusive rights to develop and commercialize the drug outside the United States, except for some Asian markets, and obtain a minority equity investment in Reata, which will receive $450 million. Reata also will receive additional milestone payments and royalties on future sales.