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.
NBTY shareholders OK adopting merger agreement
RONKONKOMA, N.Y. NBTY on Wednesday announced that its stockholders have approved the proposal to adopt the merger agreement providing for NBTY’s acquisition by an affiliate of The Carlyle Group.
The affirmative vote of the holders of a majority of the outstanding shares of common stock of NBTY was required to approve the proposal to adopt the merger agreement. According to the final tally of shares voted, approximately 50.5 million shares of common stock of NBTY voted for the approval of the proposal to adopt the merger agreement, representing approximately 79.6% of the outstanding shares of common stock of NBTY as of the close of business on Aug. 23, the record date for this vote.
Following the approval of the proposal to adopt the merger agreement by NBTY’s stockholders, all conditions to the closing of the merger set forth in the merger agreement have been satisfied (other than those conditions to be satisfied by action taken by the parties at the closing). Under the merger agreement, the affiliate of Carlyle is obligated to consummate the merger upon completion of the 20-day marketing period for the debt financing, which will commence on Sept. 23, but it is NBTY’s expectation that the merger could be completed as soon as the beginning of October.
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.