Dura’s Shares Drop as FDA Withholds OK

The Food and Drug Administration still has concerns about San Diego-based Dura Pharmaceuticals Inc.’s next-generation asthma inhaler and won’t approve the product at this time, the company said. The announcement drove Dura’s shares down 21%. The shares finished the day down $2.63 at $9.75 on Nasdaq. The FDA sent a letter to Dura and to development partner Spiros Development Corp. II, saying it has completed its review of the drug inhaler, Albuterol Spiros, but still has concerns that must be resolved before it clears the product for sale in the U.S. The action could hold up the product’s launch for at least a year. The FDA wants the company to do more trials of the inhaler, Dura said.