The Food and Drug Administration cleared Nastech Pharmaceutical's Bothell manufacturing facility to make a generic drug, but the company still faces regulatory and procedural hurdles before it can market the product.
The news today closes out a month of significant announcements for Nastech, which has seen its stock rise 15.4 percent since Feb. 1, closing Monday at $21.69, the highest level in nearly a decade.
It started with a partnership deal with Procter & Gamble worth up to $577 million. Then Nastech expanded its RNAi pipeline. Now the company is ready to manufacture calcitonin, a generic version of the osteoporosis drug Miacalcin, which it's making with Par Pharmaceutical.
But there is still an unresolved citizen petition potentially delaying FDA action on approving Nastech's generic drug, a situation detailed in this story. And Apotex applied for approval of its own generic calcitonin nasal spray before Nastech. That could mean Nastech would be delayed from marketing its generic for six months.