Amphastar Resumes Sales of Emergency Prefilled Syringes

On Aug. 5, the U.S. Food and Drug Administration announced on its “Current Drug Shortages” Web page that Amphastar, parent company to International Medication Systems (IMS), will re-introduce several emergency prefilled syringe products “in cooperation with FDA.” The products were discontinued in December 2009, and since that time EMS agencies have experienced backorders and shortages. Only one other company, Hospira Inc., manufacturers comparable products.

At press time, Amphastar expected to begin shipping the emergency prefilled drug syringes to distributors on the following tentative dates:

Aug. 25: epinephrine injection, 1:10,000, 10 mL;

Sept. 1: morphine sulfate injection, 10 mg in 10 mL;

Sept. 8: lidocaine hydrochloride injection, 2%, 5 mL;

Sept. 15: atropine sulfate injection, 1 mg in 10 mL;

Sept. 15: calcium chloride injection, 10%, 10 mL;

Sept. 29: dextrose injection, 50%, 50 mL; and

Oct. 13: sodium bicarbonate injection, 8.4%, 50 mL.

EMS Insider first reported on the drugs’ discontinuation in January. (See “Amphastar Pharma Discontinues Emergency Prefilled Meds,” January 2010.) The company wanted to continue producing the prefilled medications, but the FDA, based on a 2006 policy, was going to require Amphastar (and all other companies) to file a New Drug Application or Abbreviated New Drug Application for any drugs that had been “grandfathered” into the market without FDA approval.

The company even investigated the possibility of continuing sales while they completed the NDAs, but the FDA did not agree, said Jacob Liawatidewi, AVP of sales and marketing with Amphastar.

After weighing the costs associated with filing NDAs—which can run in the hundreds of thousands of dollars—and the possibility of having to conduct clinical trials, Amphastar decided it wasn’t in their interest to continue sales. That left only one manufacturer, Hospira, to supply the entire market.

EMS agencies are encouraged to contact their suppliers.