FDA posts, removes briefing documents regarding Seroquel XR
WILMINGTON, Del. The Food and Drug Administration posted and then removed briefing documents on its Web site for the Psychopharmacologic Drugs Advisory Committee meeting Wednesday.
The meeting concerns an application that drug maker AstraZeneca submitted for an additional use of the drug Seroquel XR (quetiapine fumarate) as a treatment for major depressive disorder and generalized anxiety disorder.
The company said it understands that some people accessed the documents before their removal, and that it wishes to ensure all investors have access to the information contained in the previously released FDA briefing materials. For that reason, it has posted the documents, as well as AstraZeneca briefing documents, on its own Web site.
Sun Pharmaceutical subsidiary extends tender offer to Taro
MUMBAI, India Sun Pharmaceutical announced Friday its subsidiary, Alkaloida, has extended the expiration date of the tender offer for the purchase of all outstanding shares of Taro.
The offer will now expire at on Friday, April 17, unless further extended or earlier terminated.
The tender offer was extended to comply with a continuing order issued by the Supreme Court of Israel, temporarily prohibiting the closing of the offer until the Supreme Court issues a decision on the appeal of the litigation commenced against Alkaloida and its affiliates by Taro and certain of its directors, regarding the applicability of the special tender offer rules under the Israeli Companies Law to the offer.
The Tel-Aviv District Court had previously ruled in favor of Sun that a special tender offer was not required. If the temporary order remains in effect on April 17, 2009, Sun expects to extend the Offer while the temporary order remains outstanding.
The offer was commenced on June 30, 2008 in order to comply with the terms of the Option Agreement between Alkaloida and the controlling shareholders of Taro. Alkaloida exercised its options to acquire shares of Taro from the controlling shareholders on June 25, 2008. The Option Agreement required Alkaloida, promptly after exercising the options, to commence a tender offer at $7.75 per share of Taro held by other shareholders.
The offer had previously been scheduled to expire at 5:00 p.m. EST, Friday, April 3. As of 5:00 p.m., New York City time, on April 2, 2009, 25,617 shares had been tendered and not withdrawn from the offer.
FDA reviews heart risks of depressive disorder medication
WASHINGTON Federal health officials said a schizophrenia drug from AstraZeneca also works against depression, though it carries risks of sudden heart death, the Associated Press reported Friday.
Seroquel XR is used by millions of patients to treat schizophrenia and bipolar disorder. Now London-based AstraZeneca wants the Food and Drug Administration to approve the drug for depression and anxiety.
Seroquel has severe side effects, including sudden death.
The company launched two new strengths of Seroquel XR (quetiapine fumarate) extended-release tablets last month. The new strengths, 50-mg and 150-mg, are in addition to the existing 200-mg, 300-mg and 400-mg strengths.