Avanir addresses the FDA’s concerns over Zenvia
ALISO VIEJO, Calif. Drug maker Avanir Pharmaceuticals has responded to the Food and Drug Administration’s concerns over a drug for treating a disease that causes bouts of laughter and crying in patients, Avanir said Friday.
Avanir said it issued a complete response to the FDA’s approvable letter from October 2006 for the drug Zenvia (dextromethorphan and quinidine), a treatment for pseudobulbar affect. “Approvable letter” is the former name for what the FDA began calling a “complete response letter” in 2008. A complete response letter means that the FDA has finished reviewing a drug company’s approval application, but questions remain that preclude final approval.
The company said it expected the FDA to grant it a review period of six months, allowing the approval of Zenvia in fourth quarter 2010.
FDA approves new use for Abbott HIV drug
ABBOTT PARK, Ill. The Food and Drug Administration has approved a new use for an HIV drug made by Abbott, the drug maker said Wednesday.
Abbott announced the approval of Kaletra (lopinavir and ritonavir) as a once-daily treatment of adults with HIV who previously have taken antiretroviral therapy. The drug already is approved as a once-daily treatment for patients who have not taken antiretroviral drugs.
“Adherence to treatment is critical to the effective management of HIV,” Baylor College of Medicine Department of Internal Medicine clinical instructor Joseph Gathe said on behalf of Abbott. “A Kaletra once-daily regimen can simplify HIV treatment and offers greater flexibility for patients.”
J&J to pay more than $80 million for unapproved promotion of Topamax
TITUSVILLE, N.J. A Johnson & Johnson subsidiary will pay more than $80 million to the federal government to settle a case involving alleged promotion of an epilepsy drug for uses not approved by the Food and Drug Administration, J&J said Thursday.
In addition to the $81.5 million plus interest that Ortho-McNeil-Janssen Pharmaceuticals will pay to the federal government, a subsidiary of Ortho-McNeil-Janssen itself, Ortho-McNeil Pharmaceutical, will accept a misdemeanor charge concerning promotion of Topamax (topiramate) between 2001 and 2003.
According to the plea agreement, Ortho-McNeil Pharmaceutical promoted Topamax for unapproved uses. The settlement follows a $520 million settlement between the government and AstraZeneca Tuesday concerning alleged off-label marketing of the bipolar disorder and schizophrenia treatment Seroquel (quetiapine fumarate).