Theravance MRSA drug a victim of Ben Venue shutdown

Vibativ, an injectable skin-infection treatment from Theravance ($THRX) that's marketed by Astellas, has fallen victim to the QA-related production shutdown at contractor Ben Venue's plant in Bedford, OH. Theravance spokesperson Cheryllyn De Ocampo confirmed by email the speculation in Friday's San Francisco Business Times.

According to Reuters, an Astellas letter informed wholesalers, distributors and the healthcare community of a hold on distribution and cited "critical product shortages [and] regional supply outages." Astellas has recommended that no new patients begin treatment with the drug, which fights gram-positive bacteria, including MRSA.

The once-daily injectable won European approval last September. It was approved in the U.S. in 2009.

Ben Venue, a unit of Boehringer Ingelheim, voluntarily suspended drug manufacturing and distribution at the Bedford plant after a joint visit by inspectors from the FDA, France and the U.K.

- see the San Francisco Business Times column
- here's the Reuters story

Suggested Articles

Recipharm has been building its capabilities in sterile injectable and inhalation drugs. Now it is buying a CDMO that manufactures devices for both.

The FDA has slapped the parent of Dollar Tree stores with a warning letter saying some CMOs that made its OTC products were among the world's worst.

GSK expects Shingrix supplies to rise slightly in 2020, but the real "step change" will come in 2024 with a brand-new manufacturing facility.