Sanofi manufacturing glitch yields insulin pen shortage

Citing a "technical incident" at a manufacturing plant in Frankfurt, Germany, Sanofi ($SNY) reports that a worldwide shortage of the Apidra Solostar insulin pen will begin this month. The incident, which involved the production of the pens but not the short-acting drug, occurred in July.

"An in-depth investigation and additional controls were immediately carried out," the company informed doctors in a letter now posted on the FDA website. "We have proactively notified" the FDA of the event.

Competing products are widely available in the U.S., Dow Jones reports.

The letter also says Sanofi expects to return to normal supply levels by the first quarter of next year. In the meantime, the company recommends that doctors consider switching patients to Apidra vials and syringes. The product currently on the market is safe, the letter says.

- here's the letter (.pdf)
- see this story

Suggested Articles

South Korea’s Celltrion, which has a massive biologics site in Songdo, has decided it is time to build some operations in China.

WuXi Biologics is taking control of a Bayer plant in Germany and agreed it could serve as a backup facility for supply of hemophilia drug Kovaltry.

A Chinese OTC drugmaker gets the distinction of ringing in the new year as the first company to be slapped with an FDA warning letter.