The FDA has approved InnoPharma’s ANDA for acetylcysteine solution. The New Jersey company has a deal with Fresenius Kabi USA to market acetylcysteine solution in the US, where there has been a shortage of the product. Bedford Laboratories recalled acetylcysteine solution earlier this year and American Regent/Luitpold has experienced recurring manufacturing problems.
According to the company, it will make acetylcysteine solution, 20% concentration in 30 ml vials, available within a few weeks.
Read the InnoPharma press release.
