Regulatory and Washington

TITUSVILLE, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating schizophrenia in adolescents.

J&J said Monday that the FDA had approved Invega (paliperidone) extended-release tablets for patients ages 12 to 17 years. The drug is marketed by J&J subsidiary Ortho-McNeil-Janssen Pharmaceuticals. The drug originally was approved in 2006 for treating schizophrenia in adults.

HAYWARD, Calif. — Another generic drug maker is seeking to market its version of a popular opioid painkiller.

Impax said it had filed applications with the Food and Drug Administration seeking approval for a generic version of Purdue Pharma’s Oxycontin (oxycodone) controlled-release tablets in the 10-, 15-, 20-, 30-, 40-, 60- and 80-mg strengths.

Purdue filed suit against Impax on April 8 in the U.S. District Courts for the Southern District of New York, seeking to prevent Impax from marketing its version before the expiration of Purdue's patents.

WASHINGTON — The Department of Health and Human Services on Friday launched two plans aimed at reducing health disparities.

“For the first time, the United States has a coordinated road map designed to give everyone the chance to live a healthy life,” stated HHS secretary Kathleen Sebelius. “We all need to work together to combat this persistent problem so that we can build healthier communities and a stronger nation.”

CINCINNATI — Procter & Gamble has announced a voluntary recall of 10 shades of its Clairol Natural Instincts in the United States, Canada and Puerto Rico because of a mismatched ColorFresh! Revitalizer sachet in the kits that may create an unwanted color result.

AMITYVILLE, N.Y. — The Food and Drug Administration has granted tentative approval to a generic antibiotic made by Hi-Tech Pharmacal, the drug maker said Friday.

Hi-Tech announced the tentative approval of levofloxacin oral solution in the 25 mg-per-mL strength. The drug is used to treat mild, moderate and severe bacterial infections in adults.

ALEXANDRIA, Va. — A Georgetown University Health Policy Institute study of Florida’s Medicaid Managed Care pilot program should raise doubts for states considering the use of for-profit managed care companies to reduce Medicaid costs, the National Community Pharmacists Association cautioned on Friday.

PARSIPPANY, N.J. — Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

Watson Labs filed an abbreviated new drug application with the Food and Drug Administration for moxifloxacin hydrochloride ophthalmic solution USP in the 0.5% strength. The antibiotic solution is a generic version of Alcon's Vigamox, which had total U.S. sales of about $281 million ended in February, according to IMS Health.

ALEXANDRIA, Va. — In anticipation of Earth Day 2011 on April 22, the National Community Pharmacists Association is encouraging community pharmacists to demonstrate their role as a respected and knowledgeable resource on all aspects of medications, from dispensing to disposal, the association announced Thursday.