Content about Antidepressant

DEERFIELD, Ill. — The Food and Drug Administration has accepted a regulatory approval application from Takeda and Lundbeck for an experimental drug to treat depression, the companies said Wednesday.

The FDA will review the companies' application for vortioxetine for the treatment of major depressive disorder in adults. The agency expects to finish reviewing the application by Oct. 2, 2013.

INDIANAPOLIS — Eli Lilly announced that it has met Food and Drug Administration requirements for pediatric exclusivity for its antidepressant medication.

Based on this decision by the FDA, Lilly has gained an additional six months of U.S. market exclusivity for Cymbalta (duloxetine hydrochloride), which now will expire in December 2013.

WASHINGTON — Women take mental health drugs at a much higher rate than men, according to a new study by one of the country's largest pharmacy benefit managers.

Medco Health Solutions released results of the study Monday, showing that 25% of women use psychotropic drugs, compared with 15% of men. The study was based on the pharmacy claims of more than 2 million Americans and measured the use of drugs for treating depression, anxiety, attention deficit hyperactivity disorder and psychotic disorders between 2001 and 2010.

NEW YORK — GlaxoSmithKline can sell an authorized generic of its antidepressant drug to Toronto-based drug maker Apotex, a U.S. judge ruled.

According to a Bloomberg Businessweek report, U.S. District Court judge Joe Pisano ruled the agreement was valid.

WINSTON-SALEM, N.C. — AstraZeneca and Targacept released results of the second of four phase-3 clinical trials that investigated the efficacy and tolerability of a drug that could serve as an adjunct therapy to major depressive disorder patients that had an inadequate response to initial antidepressant therapies.

NEW YORK — AstraZeneca and Targacept released results of the first of four phase-3 clinical trials that investigated the efficacy and tolerability of a drug that could serve as an adjunct therapy to major depressive disorder patients that had an inadequate response to initial antidepressant therapies.

AUSTIN, Texas — The Food and Drug Administration has approved a new strength for a psychiatric drug made by Edgemont Pharmaceuticals, Edgemont said Tuesday.

The drug maker announced the approval of a 60 mg dose of fluoxetine tablets, a treatment for major depressive disorder, obsessive compulsive disorder, bulimia nervosa and panic disorder. The drug was originally marketed under the brand name Prozac.

NEW YORK — Patients taking an investigative antidepressant undergoing late-stage clinical development showed “significant” improvement, according to study results released Monday.

Forest Labs and Pierre Fabre Medicament announced results of a phase-3 trial of levomilnacipran in adults with major depressive disorder. Results showed a statistically significant improvement in patients treated with the drug, compared with those taking placebo.

FRANKLIN LAKES, N.J. — Pharmacy benefit manager Medco’s research arm is teaming up with personalized medicine and pharmacogenetics company AssureRx Health in a pilot program to evaluate adherence and medical care utilization among patients taking antidepressants and antipsychotics.

ST. LOUIS — Patients who take generic antidepressants will remain as adherent as those who take brand-name drugs to treat the condition, according to a new study.

The study, conducted by Express Scripts and published in the Journal of Managed Care Pharmacy, found patients starting generic selective serotonin reuptake inhibitors and generic selective norepinephrine reuptake inhibitors had a discontinuation rate of 44.2%, compared with 46.8% among those on brand-name SSRIs and SNRIs.

BALTIMORE — If the government paid for drug cost incentives for Medicare patients with congestive heart failure, the program could recoup those costs and more by spending less on expensive hospitalizations for patients. 


That finding was one of several to emerge from research conducted by pharmacy students at the University of Maryland School of Pharmacy. The four students presented their findings on elderly drug adherence at the annual meeting of the Gerontology Society of America in New Orleans.

LONDON British drug maker GlaxoSmithKline will pay nearly $1 billion to the U.S. government to settle allegations that it sold contaminated and ineffective products.

The company will plead guilty to criminal charges relating to drugs made at a manufacturing plant in Cidra, Puerto Rico, which it closed in 2009, and pay $750 million. In a whistleblower suit filed by a former employee, it was alleged that the company knowingly sold defective supplies of various drugs, including the baby ointment Bactroban (mupirocin) and the antidepressant Paxil (paroxetine).