FDAnews Drug Daily Bulletin

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.

Teva Pharmaceutical has settled patent litigation with GlaxoSmithKline (GSK) that will enable it to market a generic version of GSK's Lamictal.

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 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).

Genzyme, a biotechnology company, has announced the expansion of its Asia-Pacific regional office in Hong Kong.

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.

One of Austin's brightest bioscience companies, Esoterix Inc., reportedly is for sale and could fetch as much as $240 million.

Valera Pharmaceuticals has entered into an agreement with BioPro Pharmaceutical (USA), based in San Francisco, Calif.

Drugmaker Bradley Pharmaceuticals Inc. reported Monday that the Securities and Exchange Commission launched an informal probe to determine if the company violated securities laws.

Integrated systems biology company Icoria has licensed to Syngenta the exclusive rights to commercially develop 30 Icoria compounds believed to be active fungal inhibitors.

Evotec OAI AG, a leading partner for integrated high-value-added drug discovery and development solutions to the pharmaceutical and biotechnology industries, has announced that it will support Mitsubishi Pharma, Osaka, Japan, in its medicinal chemistry programs.