Sanofi manufacturing delays trigger TB drug shortage

Sanofi ($SNY) manufacturing delays have put its tuberculosis drug Rifamate on the FDA shortage list. The pill combines the antibiotic rifampin with isoniazid, a commonly used TB treatment that's been running scarce for several months.

The FDA notice states that Sanofi expects to resume shipping Rifamate in June, making it available for patients in July. The Centers for Disease Control and Prevention says isoniazid and rifampin are the two most important treatments for TB.

The isoniazid shortage emerged in November, when state TB programs notified the CDC that tablets were scarce. Only three companies sell the drug in the U.S.: VersaPharma, the Novartis generics unit Sandoz, and Teva Pharmaceutical Industries ($TEVA). At the time, the CDC noted that Sanofi's combination pill was still available.

According to the FDA, isoniazid versions made by VersaPharm are still out of stock and aren't expected to return till January of next year. Sandoz has some strengths now available, though one product is still on backorder. Teva's 300 mg strengths are all available, but its 100 mg pills are on limited supply through next month. Teva also has set up an "emergency reserve" in cooperation with the FDA and CDC.

The FDA's shortage report cites "other" as the reason behind Sanofi's shortage. Sanofi didn't respond to a request for comment by press time. So, it's unclear whether the company's combo pill is running short partly because of the problems with isoniazid supply or simply because of production delays.

It isn't the first time Sanofi has been involved in a TB-related shortage. Last summer, the company's vaccines unit pulled four batches of the TB vaccine BCG. Australian regulators had flagged sterility problems at the Sanofi Pasteur plant, which had flooded months before. The company suspended production of the shot, and later shut the plant for fixes.

- see the FDA shortage list
- read the Outsourcing-Pharma story

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