Drug Industry Daily

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The FDA has approved Eisai’s Fycompa tablets to treat partial-onset seizures in epilepsy patients ages 12 and older.

The FDA has given $2.7 million to University of Cincinnati researchers to study whether generic versions of the transplant drug Prograf have the same efficacy as Astellas Pharma’s branded product.

Eli Lilly’s once-weekly Type 2 diabetes candidate dulaglutide met its primary endpoint for hemoglobin A1c reduction in top-line results from three studies.

The FDA has approved Supernus Pharmaceuticals’ Oxtellar XR as a once-daily therapy for epilepsy and the company plans to launch the drug next year. 

API makers with manufacturing facilities in Canada can expect nearly $1 million dollars in initial costs and $100,000 in annual compliance and administrative costs related to proposed manufacturing regulations.

The FDA has released two lists of customers that received products shipped on or after May 21 from New England Compounding Center’s (NECC) Framingham, Mass., facility.