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Impax Labs receives FDA approval for generic version of Depakote

Impax Laboratories has confirmed that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company’s Abbreviated New Drug Application (ANDA) for generic version of Depakote® (divalproex ER) 500mg Extended-release Tablets.

5 Aug 2009

Seroquel XR supplemental NDA recommended for approval

The U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) conducted a review of the safety and efficacy of supplemental new drug applications (sNDA) for Seroquel XR (quetiapine fumarate) extended-release tablets proposed for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD).

9 Apr 2009

FDA requires stronger warnings on antiepileptic medicines

The U.S. Food and Drug Administration has announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.

16 Dec 2008

Save money wih generics

Today, more than ever, consumers can opt for generic equivalents of brand-name medications at substantial cost savings.

10 Dec 2008

FDA approves first generic divalproex sodium for the treatment of seizures, bipolar disorder and migraine headaches

The U.S. Food and Drug Administration today approved the first generic versions of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches.

29 Jul 2008

AstraZeneca submits sNDA for SEROQUEL XR for treatment of major depressive disorder

AstraZeneca has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for once- daily SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of major depressive disorder (MDD) as monotherapy, adjunct therapy, and maintenance therapy in adult patients.

1 Mar 2008

Oxcarbazepine doesn't prevent migraine

Contrary to some reports, the epilepsy drug oxcarbazepine does not appear to prevent migraine, according to research published in the February 12, 2008, issue of Neurology®, the medical journal of the American Academy of Neurology.

12 Feb 2008

AstraZeneca submits sNDAs for SEROQUEL XR for bipolar symptoms

AstraZeneca has announced that the company has submitted two separate supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) for once-daily SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of manic episodes associated with bipolar disorder and the treatment of depressive episodes associated with bipolar disorder.

3 Jan 2008

Researchers are comparing two drugs used to treat pediatric bipolar disorder

University of Illinois at Chicago researchers are comparing two drugs used to treat pediatric bipolar disorder patients to evaluate how the drugs affect brain function in children with the disorder.

25 Oct 2004