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Impax Laboratories Inc. has filed a motion in the U.S. District Court for the
District of Columbia to intervene as a defendant in a lawsuit by Barr Laboratories,
Inc. against the FDA. Earlier this month, Barr Laboratories, a subsidiary of
Barr Pharmaceuticals Inc. brought suit against the FDA in an attempt to prevent
the agency from granting final approval to Impax's abbreviated new drug application
(ANDA) for its fexofenadine HCl and pseudoephedrine HCl extended-release tablets,
a generic version of Allegra-D.
The FDA has announced the availability of final guidance for industry on how
to conduct a safety review of a new drug application (NDA) and a biologics license
application (BLA).
Drugmakers should consult with the FDA before drafting their first electronic
common technical document (eCTD) submission to ensure the documentation is prepared
properly and conforms to agency requirements, advises a Center for Drug Evaluation
and Research (CDER) official.
The European Medicines Agency (EMEA) has become the first regulatory body to
impose sweeping restrictions on Cox-2 inhibitor drugs, announcing recently that
it will require labeling changes and physician warnings for the controversial
drug class.
The law firm of Milberg Weiss Bershad & Schulman LLP announces that a class
action lawsuit was filed today on behalf of all persons who purchased or otherwise
acquired the securities of Axonyx between June 26, 2003 and Feb. 4, 2005, inclusive,
seeking to pursue remedies under the Securities Exchange Act of 1934.
FedEx Corp. has stopped delivering packages from online pharmacies to portions
of eastern Kentucky where prescription drug abuse has become widespread.
Leading brokers slashed sales forecasts for AstraZeneca cholesterol drug Crestor
on Friday, lopping more than 1.5 percent off shares in Europe's third largest
drugmaker.