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Tetracycline Shortage To Go On as US FDA Cannot Find New Source

By Zachary Brennan , 23-Jul-2013

The current US shortage of tetracycline is not likely to be resolved any time soon because of ongoing manufacturing and raw material supply issues according to the US FDA.

Tetracycline – which is broad spectrum antibiotic used to treat a variety of infections –has been in short supply in the US since mid-2011 when difficulties sourcing raw materials halted production at Watson and Teva, which are the only firms to make the drug for the US market.

These problems persist according to US Food and Drug Administration (FDA) Lisa Kubaska, who told in-Pharmatechnologist.com that in addition to the API sourcing issues encountered by Watson and Teva, the FDA has “not found a source for importation.”

She explained that sometimes when there are such shortages, the agency looks for alternative drug sources produced at foreign manufacturing facilities that have already been visited by its inspection teams.

There is some light at the end of the tunnel. Watson, which acquired Actavis and took on the name afterwards, is expected to release tetracycline in Q4 of this year according to the FDA’s drug shortage list .

Supply issues

Dave Belian, Actavis spokesman, confirmed the timeline and stressed that a shortage of raw materials rather than manufacturing issues had caused the problems. He also told in-Pharmatechnologist.com he did not know what was holding up the company’s API supplier.

For Teva things look less likely to improve in the short term. Company spokeswoman Denise Bradley told us, “We currently have a shortage due to API constraints – we do not have a qualified provider at this time. We cannot estimate a release date.”

FDA’s Kubaska added: “FDA will continue to assist the firms with anything they need assistance with to come back on the market.  FDA does not recommend alternatives, however we do know that doxycycline and minocycline remain available.”

The most common current use of the antibiotic is in the treatment of moderately severe ace and rosacea, though it can also be used to treat infections of the urinary tract and the intestines, as well as a chlamydia treatment.

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