Nastech Pharmaceutical Co., Inc.

PAI complete for nasal-spray facility

Published in Drug Law Weekly, June 29th, 2004

Nastech Pharmaceutical Co., Inc., (NSTK) announced that the U.S. Food and Drug Administration (FDA) has successfully completed the preapproval inspection (PAI) of the company's manufacturing facility for both the Nascobal Nasal Spray product for treatment of vitamin B-12 deficiencies and the Salmon-Calcitonin Nasal Spray product for osteoporosis.

Both product candidates are under FDA review for marketing clearance.

"We are delighted to have completed these two successful FDA PAI of our manufacturing facility without receiving a Form 483, which is the document used by FDA investigators to record observations of noncompliance with current good...

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Source: Drug Law Weekly (2004-06-29)

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