India's Claris Lifesciences thought it had landed a prize when the FDA approved its generic version of Lasix for sale in the U.S. last year. At that point, furosemide had been on the FDA shortage list for 18 months and there was big demand. But this year Claris ran into supply issues of its own, which it has now gotten on top of.
The company reported to the Bombay Stock Exchange on Wednesday that the FDA had given it a prior approval supplement (PAS) for furosemide injection, allowing it to add another raw materials supplier to its ANDA. Its filing said the approval should provide it with a consistent supply of raw materials and redundancy. It said that since January of this year, its original supplier has had supply issues that have kept Claris from being able to get product to the U.S.
The FDA no longer lists furosemide injection on its shortage list, but the pharmacy group ASHP still has some dose sizes of the drug for treating liquid retention listed as being difficult to get.
There have been reports that Claris had its sterile injectables business up for sale and that Pfizer ($PFE), Indian competitor Zydus Cadila and others had been checking it out. But new reports suggest a deal with Zydus may have gotten off track after an FDA inspection of a Claris plant resulted in FDA observations. In 2012, Claris dug itself out from under a two-year ban by the FDA on plants in India and the U.S. that was imposed over contamination concerns.
- here's the BSE announcement