Drug Industry Daily

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Adverse events associated with Eli Lilly’s depression medication Cymbalta and other well-known drugs are included in the first version of what the FDA says will be a regular series of quarterly reports.

Several months after the FDA withdrew a direct final rule modifying certain provisions of good manufacturing practice (GMP) regulations, the agency is finalizing new GMP regulations that include limited changes to its original.

Roughly a week after Hi-Tech Pharmacal filed a complaint against the FDA to force it to confirm the company is entitled to a period of market exclusivity for generic Cosopt, the agency has requested comment about when ANDAs for the drug should be eligible for final approval.

Elan and Biogen Idec have started a Phase I/II clinical trial of their multiple sclerosis drug Tysabri to treat multiple myeloma, a plasma cancer.

The FDA is requesting information on the abuse potential and the impact from changes in scheduling for 10 drug substances — including dextromethorphan, a common OTC cough suppressant.