Janssen’s attempts to turn two HIV pills into one daily dose has been shot down by the FDA. The J&J subsidiary was seeking approval of an 800mg tablet of Prezista (darunavir), so patients could take one pill instead of two of the currently approved 400mg tablets. Janssen submitted the NDA in January and said in a press release that it does not expect to run additional trials as a result of the Complete Response Letter. The drug is taken along with 100mg of retinovir and other medications.
The honeymoon for J&J’s CEO Alex Gorsky is over. The FDA issued a warning letter to the pharmaceutical giant May 22 and has given the company just 15 business days to correct manufacturing and quality control problems. The FDA noted that some of the issues are repeats of issues that were identified in a 2009 FDA inspection. Among those issues:
• Closing 68 medical complaints about K-Y Liquibeads Vaginal Moisturizer without proper evaluation or investigation
• Failure to review and investigate complaints that should be reported to the FDA
• Misbranding Reach dental floss and OB Tampons
• Failing to report that Reach and OB tampons were linked to consumer injury
• Poor manufacturing and unapproved distribution of K-Y Liquibeads Vaginal Moisturizer
