Shire seeks FDA approval for ADD drug
Boston Business Journal - Boston Business Journal
Shire PLC, which has a large employment presence in Massachusetts, has filed an FDA application seeking approval for a new treatment for attention-deficit and hyperactivity disorder.
The company (Nasdaq: SHPGY), which has headquarters operations both in the United Kingdom and Philadelphia, said it had filed a new drug application for guanfacine extended release, with a proposed trade name of Connexyn.
The U.S. Food and Drug Administration has 10 months to review the application for the drug, which would represent a new treatment option for the disorder.
Shire acquired Transkaryotic Therapies Inc. in Cambridge last year for $1.6 billion. Transkaryotic became Shire's human genetics therapies division, which employs at least a few hundred people locally.
Elaprase, which was developed by TKT and is now owned by Shire, recently gained FDA approval as a human enzyme replacement therapy to treat Hunter syndrome.
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