Risperdal, which has already been cleared by the FDA as a treatment for bipolar disorder, is one of J&J’s biggest products, with annual sales of about $3 billion.New Brunswick”s Johnson & Johnson (NYSE: JNJ) said Thursday its pharmaceutical research and development unit has received a “not approvable” letter from the U.S. Food and Drug Administration regarding a supplemental application for Risperdal as a treatment for psychosis related to Alzheimer”s disease.
Johnson & Johnson said its Johnson & Johnson Pharmaceutical Research & Development unit in Raritan will review the “not approvable” letter to determine what to do next.
Johnson & Johnson made the announcement prior to a meeting with analysts and investors in New York City during which the company said it has 17 new medicines in advanced stages of clinical testing or awaiting approval by regulators.
Risperdal, which has already been cleared by the FDA as a treatment for bipolar disorder, is one of J&J”s biggest products, with annual sales of about $3 billion.
The drug, however, faces competition from Eli Lilly”s Zyprexa, AstraZeneca”s Seroquel, Pfizer”s Geodon and Bristol-Myers Squibb”s Abilify. To boost market share, the companies are seeking to win approval for additional indications for their drugs.
This latest rejection by the FDA follows a “not approvable” letter issued May 20 to Johnson & Johnson Pharmaceutical Research & Development regarding a supplemental new drug application for Risperdal in the treatment of autism.
At the close of trading, Johnson & Johnson shares were down $0.05 at $67.42.