Amid supply shortage, FDA clears import of in-demand drug
- New York-based drugmaker Athenex, Inc. said it has secured clearance from the Food and Drug Administration to import sodium bicarbonate 8.4% injection to help alleviate a national drug shortage for the product, which is often used in hospitals for patients whose blood has become too acidic.
- Athenex began importing vials of the injection solution in early June, tapping the Australian manufacturer Phebra Pty Ltd for supply.
- Securing clearance from the FDA will allow Athenex to import the product through February 2018 or the duration of the shortage, the company said.
Shortages at Pfizer's Hospira unit, one of the main manufacturers in the U.S. for medical sodium bicarbonate, has had knock-on effects throughout the distribution chain for the basic, but vital, drug.
The shortage led to a spike in demand for product from Amphastar, triggering further shortages and putting pressure on hospitals, per The New York Times.
Adding to the problem, Hospira announced a voluntary withdrawal of several products in June, including 42 lots of sodium bicarbonate injection from the U.S. market.
According to an FDA database of drug shortages, Hospira anticipates its next delivery of a pediatric version of the injection in September, while other 8.4% vials will be delivered in late July. Delivery of another type of single dose glass vial remains to be determined due to third part manufacturing delays.
Estimated stabilization of supply is not expected until the first quarter of 2018.
In the interim, the FDA has cleared Athenex to import product from an Australian manufacturer — essentially declaring it will not object to the imports rather than approve the Aussie company's version of the drug. Amphastar now also has some supplies available, according to the database.
Hospira has routinely had issues with both manufacturing and supply of various products in its portfolio, giving Pfizer headaches ever since the big pharma acquired it in 2015.
- Athenex, Inc. Press release
- BioPharma Dive Drug supply shortage forces upheaval, care dilemmas on US hospitals
- BioPharma Dive Hospira recalls add to drug shortages
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