From Forbes.com:

Drug developer Eli Lilly & Co. said Monday the Food and Drug Administration approved the bipolar depression drug Symbyax as a therapy for treatment-resistant depression.

The new indication applies to adult patients who have not responded to two separate rounds of therapy with different antidepressants.

The FDA also approved the combined use of Zyprexa and fluoxetine, or Prozac, as a treatment for depression and treatment-resistant depression. Zyprexa is already approved for schizophrenia and bipolar disorder.

And from PR Newswire - Forest Laboratories, Inc. Announces FDA Approval of Lexapro(R) for the Treatment of Major Depressive Disorder in Adolescents:

Forest Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) for Lexapro (escitalopram oxalate) for the acute and maintenance treatment of Major Depressive Disorder (MDD) in adolescents, 12 - 17 years of age. Lexapro is only the second antidepressant to be approved for the treatment of MDD in adolescents, a medical condition that affects approximately 2 million adolescents in the U.S.

"Major depressive disorder in adolescents is a debilitating, but treatable illness," said Howard Solomon, Chairman and Chief Executive Officer, of Forest. "We have long believed that Lexapro would be of benefit for the treatment of depression in adolescents and that is why we undertook the several studies described in the package insert. We are enormously gratified that Lexapro will be available for depressed adolescents who so much require the benefits which Lexapro has made available for depressed adults for the past seven years."

The approval of Lexapro for the treatment of adolescent depression was supported by two placebo-controlled studies, one conducted in adolescent patients taking Lexapro and one conducted in children and adolescents taking citalopram. In an 8-week flexible- dose, placebo-controlled study that compared Lexapro 10-20 mg/day to placebo in 12 to 17 year old patients reported in 2008, Lexapro showed statistically significant greater mean improvement from baseline, compared to placebo, on the Children's Depression Rating Scale-Revised (CDRS-R).

In another 8-week, flexible-dose, placebo-controlled study, children and adolescents 7 to 17 years of age treated with racemic citalopram 20-40 mg/day showed statistically significant greater mean improvement from baseline on the CDRS-R compared to patients treated with placebo. The positive results for this trial largely came from the adolescent subgroup. The FDA's determination of the efficacy of Lexapro in the acute treatment of MDD in adolescents was established, in part, on the basis of extrapolation from this study.

Although maintenance efficacy in adolescent patients has not been systematically evaluated, the FDA in its review concluded that maintenance efficacy can be extrapolated from adult data along with comparisons of escitalopram pharmacokinetic parameters in adults and adolescent patients.

Lexapro was generally well tolerated. The overall profile of adverse reactions in pediatric patients was generally similar to that seen in adult studies and is described in the package insert.

From NewsInferno.com:

Even though Lexapro and Celexa were both proven to promote suicidal thoughts in children, Forest Laboratories chose to market its antidepressants to pediatric patients anyway, prosecutors at the U.S. Justice Department have charged.

According to the Wall Street Journal (WSJ), the same prosecutors have charged that Forest Labs also violated anti-kickback laws by paying doctors to prescribe Lexapro and Celexa to vulnerable, pediatric patients. A lawsuit filed by the department now accuses the drug maker of violating the False Claims Act when it marketed the drug, The civil complaint also accuses Forest of covering up a medical study that concluded that Lexapro and Celexa were not effective medications for children, said WSJ. The complaint was unsealed in Boston federal court yesterday.

According to Bloomberg.com, the complaint charges that Forest was unwavering in its marketing of the drugs. Knowing that they were ineffective in children and could also cause suicidal thoughts in pediatric patients, Forest went ahead and promoted Lexapro and Celexa for use in children, going so far as to cite a study that was more conducive to its needs and hiding the negative findings. Meanwhile, the U.S. Food and Drug Administration (FDA) never approved the drugs for use in children.

According to the DOJ, Forest’s bribes and inappropriate marketing resulted in false claims submission for reimbursement to federal health care programs said the Journal. Bribes included not just cash payments—falsely described as grants and consulting fees—but pricey meals and other expensive gifts which violated anti-kickback laws, said Bloomberg. “By knowingly and actively promoting these antidepressants for off-label pediatric use without disclosing the results of the negative pediatric study, and by paying kickbacks, Forest caused false claims to be submitted to federal health care programs,” Massachusetts U.S. Attorney Michael Sullivan said in the complaint, reported Bloomberg.

Now, under the federal False Claims Act, the DOJ is looking for triple the financial damages from Forest in addition to other penalties; the total compensation sought is unknown, said the Journal. Bloomberg noted that under the Act, the government is eligible to receive treble damages and civil penalties of up to $11,000 per violation.

This case and others may be evidence that the DOJ is making a concerted effort to crack down on the illegal drug marketing practices. The Journal pointed out that just last week, the DOJ joined a whistle blower lawsuit against Johnson & Johnson in which the drug maker is charged with illegally marketing its cardiac medication Natrecor. Also, last month, Pfizer Inc. and Eli Lilly & Company both agreed to payouts in two separate cases involving illegal marketing, said the WSJ. Pfizer agreed to pay over $2 million in response to charges it illegally promoted it now-withdrawn painkiller Bextra. Eli Lilly agreed to pay $1.4 billion in fines to settle similar claims over its antipsychotic Zyprexa.

From the Associated Press:

Doctors may want to give stroke victims antidepressants right away instead of waiting until they develop depression, a common complication, new research suggests.

The findings may lead to an expanded use for antidepressants. Someday high-risk people like stroke patients might take the drugs before suffering depression — just as people now take cholesterol drugs to prevent heart attacks, the lead author said.

The researchers gave low doses of the antidepressant Lexapro to stroke patients. The patients on the drug were 4.5 times less likely to develop depression than patients taking a dummy pill.

More than 700,000 Americans suffer strokes each year and more than one-third will develop depression in the next two years. Stroke patients with depression recover more slowly and are more likely to die, according to previous research.

Experts say strokes may damage parts of the brain affecting mood. Add to that the stress of relearning simple tasks and adjusting to stroke-caused impairments and you've got a recipe for depression.

Lexapro may work by making the chemical serotonin more available in the brain and by promoting brain repair, said Dr. George Bartzokis of the University of California, Los Angeles, who was not involved in the new study.

"Treating the depression may actually help treat the stroke and vice versa," Bartzokis said.