Statement by Wyeth Pharmaceuticals supporting the U.S. Food and Drug Administration (FDA) Joint Advisory Committee's recommendation to strengthen the product labels across the antidepressant category re
Roche and Trimeris today announced that FUZEON(R) (enfuvirtide), the first and only fusion inhibitor available for the treatment of HIV, will now be available through retail and specialty pharmacies across the U.S. beginning on April 26. This dev
Dutch biotechnology company Crucell and the International AIDS Vaccine Initiative (IAVI) have signed an exclusive license agreement to develop an AIDS
Eli Lilly and Company and Boehringer Ingelheim have announced that the Committee for Medicinal Products in Human Use (CHMP) of the
The 21st century is shaping up to be the "century of vaccines," as vaccine developers make striking progress against both emerging and longstanding diseases, according to Vaccines: Preventing Diseases and Protecting Health, from the
Roche and GlaxoSmithKline announced today the submission of a Marketing Authorisation Application to the European authorities for a novel, once-monthly or
Isis Pharmaceuticals announced today that Eli Lilly and Company licensed LY2275796, a second-generation antisense anti-cancer drug candidate for cli
Cytogen Corporation today announced the presentation of new data relating to its lead therapeutic product Quadramet (samarium Sm-153 lexidronam injection) during the 36th Congress of the
Maxim Pharmaceuticals today announced that its treatment protocol to provide its investigational drug Ceplene(TM), in combination with interleukin-2 (IL-2), for the treatment of patients with advanced malignant melanoma,
Researchers at the University of Pennsylvania School of Medicine have concluded the world's largest analysis of penicillin allergy due to re-prescription of the popular antibiotic. Their initial findings may eventual
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) made significant changes to the generic drug approval process designed to provide more certainty to the generic drug approval process and help get generic drugs to the market more quickly. As indicated in our March 3, 2004, Federal Register notice (69 FR 9982), FDA has been considering what steps to take in light of the passage of the MMA. This guidance is one step.
As directed by the MMA, this document provides guidance on the definition of a listed drug. A listed drug is required to be referenced in a generic application and indicates the approved drug the generic company is relying upon for approval of its version of the product. The guidance is intended to clarify when a change to a generic application should reference a different listed drug from the listed drug referenced in the original generic application, and thus be made through the submission of an entirely new application that encompasses the desired change.
The document also provides guidance to industry on certain sections of the MMA that significantly change provisions of the Food, Drug, and Cosmetic (FD&C) Act that were originally added by the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (Hatch-Waxman).
These provisions affect the Act's 30-month stay of approval of a generic or section 505(b)(2) application upon the filing of a patent infringement suit and the 180-day exclusivity periods available to the first generic applicants to challenge innovator patents.
This guidance clarifies changes made by the MMA with respect to (1) the availability and termination of 30-month stays of approval of generic and section 505(b)(2) applications, (2) requirements for notice of patent certifications (paragraph IV certifications) by generic and section 505(b)(2) applicants, and (3) the 180-day exclusivity for "first" generic applicants. The guidance also explains the various effective dates that apply to the MMA's generic drug provisions.
http://www.fda.gov