AstraZeneca waits for possible launch of generic versions of its big-selling drugs
WASHINGTON AstraZeneca is waiting to see if generic companies Teva Pharmaceutical and Ranbaxy Labs, will begin selling generic versions of its drugs Nexium and Seroguel based on the expiration of a temporary ban against the companies.
According to published reports, AstraZeneca has been trying to protect its patents for Nexium (heartburn) and Seroquel (schizophrenia), by suing the two generic companies for allegedly violating AstraZeneca’s drug patents. The patents on Seroquel and Nexium patents do not expire until 2011 and 2014, respectively, and the company had won a 30-month ban—implemented by the Food and Drug Administration..
Since the lawsuits are still pending, however, there has been uncertainty on whether Teva and Ranbaxy will decide to market the pills now, as Ranbaxy will be able to sell the generic version of Nexium in the U.S. on April 14, and Teva’s ban on selling the generic version of Seroquil expired on March 26.
There has been no statement from either company on what their decision will be. The downside for them is that should they decide to sell the generic versions, they would likely have to pay AstraZeneca in damages if they are eventually found guilty. The hearing is set to start on August 11.
AstraZeneca has seen its stock fall by 23 percent over the past year.
Study shows no increased heart risk for newborns with mothers on Paxil
TORONTO According to a new study published in the American Journal of Psychiatry, infants whose mothers took the GlaxoSmithKline antidepressant drug Paxil during early pregnancy do not have an increased risk of heart defects.
The study was performed by the Motherisk program at the Hospital for Sick Children and University of Toronto. Almost 1,200 infants were studied and the results showed that infants who had been exposed to the medication had the same risk for the defects as infants not exposed, 0.7 percent.
GSK had originally published a report stating that risk of cardiovascular defects was 2 percent. Adrienne Einarson, the lead author of the new report called GSK’s initial report, “preliminary information.” GSK later adjusted its figure to 1.5 percent.
In general, the incidence of heart defects in the general population is about 1 percent.
Personal injury lawsuit filed against makers of contaminated drug Heparin
CAMDEN, N.J. A personal lawsuit against Baxter Healthcare has been filed following a near fatal reaction to the contaminated prescription drug Heparin, according to published reports.
Accounts of deaths and hundreds of severe allergic reactions stemmed from an active ingredient in the drug, which was identified as a chemically altered form of chondroitin sulfate. According to published reports, the chemical serves as a dietary supplement made from animal cartilage that is used to treat joint pain.
The contamination was rooted in China, where the drug is manufactured. The Federal Drug Administration filed a report on March 19 alerting the public of the dangers of taking the Heparin, and the medications were almost immediately recalled as a result.
“Prescription drug manufacturers have a duty to produce products that are safe and free of dangerous ingredients,” stated Wendy Fleishman of the New York City office of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein. “Only through a lawsuit or otherwise making a claim against Baxter can patients obtain compensation for their injuries. The American public needs the drug companies, like Baxter, to take responsibility for the safety of their products—especially those like Heparin, which are manufactured in part in China.”
The suit claims that Baxter did not adequately inspect the product before selling it, making them negligent, and as a result contributing to many unnecessary deaths.