FDA extends review time of AstraZeneca’s vandetanib
LONDON — A new drug application for Anglo-Swedish drug maker AstraZeneca’s vandetanib has been extended.
The drug maker recently announced that the Food and Drug Administration asked AstraZeneca to submit a Risk Evaluation and Mitigation Strategy, which accordingly extended the Prescription Drug User Fee Act from Jan. 7 to April 7.
AstraZeneca will continue to work closely with the FDA to support the review of vandetanib, a drug for treating patients with advanced medullary thyroid cancer.
GSK to pay legal charge relating to Avandia
LONDON — Drug maker GlaxoSmithKline will take a legal charge of $3.4 billion related to its promotion of a controversial diabetes drug.
The British company said the charge related to an investigation by the U.S. Attorney’s Office for the District of Colorado regarding sales and promotion of the drug Avandia (rosiglitazone) in spite of reports of the risk of heart attacks in patients taking it.
“We recognize that this is a significant charge, but we believe the approach we are taking to resolve long-standing legal matters is in the company’s best interests,” GSK SVP global litigation P.D. Villarreal said. “We have closed out a number of major cases over the last year, and we remain determined to do all we can to reduce our litigation risk.”
Court: Teva, Barr Labs must hold off on generic versions of Sensipar
THOUSAND OAKS, Calif. — Generic drug maker Teva Pharmaceutical Industries and subsidiary Barr Labs are prohibited from marketing a generic version of an Amgen drug for patients with chronic kidney disease until the drug’s patents expire, under a recent court decision.
Amgen announced that a U.S. District Court in Delaware ruled that the two companies would have to hold off launch of their version of Sensipar (cinacalcet) until 2018, when the last patent expires. The drug is used to treat secondary hyperparathyroidism in patients with CKD and elevated levels of calcium in patients with parathyroid carcinoma.
“We are pleased with the court’s ruling, which validates Amgen’s position that the Sensipar patents are valid, enforceable and infringed,” Amgen SVP, general counsel and secretary David Scott said. “Amgen will continue to vigorously defend its innovative products from infringement.”