Home » Postmarketing Studies for Shire's Drug Need Approval, FDA Says
Postmarketing Studies for Shire's Drug Need Approval, FDA Says
August 17, 2007
The FDA has sent a letter to Shire Pharmaceuticals saying that it must get approval of postmarketing studies for its drug Proamatine, which is used to treat symptomatic orthostatic hypotension, or the new drug application (NDA) may be withdrawn. The letter was also sent to several manufacturers of generic versions of the drug.