Johnson & Johnson's bid to get approval in the USA for a once-daily tablet of its HIV blockbuster Prezista has hit a regulatory hurdle.
The healthcare giant's Janssen Therapeutics unit says that the US Food and Drug Administration has issued a complete response letter for a supplemental New Drug Application for an 800mg tablet of Prezista (darunavir). The protease inhibitor, first approved in the USA in 2006, is currently taken by patients as two 400mg pills once a day with ritonavir 100mg and other antiretrovirals.
The sNDA for the 800mg pill was submitted in January and Janssen said it is evaluating the CRL. The company stressed that it does not expect additional clinical trials will be required to address the FDA's concerns and will respond "as quickly as possible".
Prezista is a big earner for J&J and first-quarter sales reached $324 million, a rise of 21.8%.
J&J blasted following vaginal moisturiser complaints
Meantime, the FDA has issued a warning letter to J&J's McNeil PPC unit saying that the firm did not adequately deal with complaints about a variety of products, most notably its K-Y liquibeads vaginal moisturiser.
The agency says that the latter and a number of other products, including tampons and dental floss were adulterated and did not meet current good manufacturing practice requirements. The FDA is particularly critical of a "failure to establish and maintain adequate complaint files", noting that some 227 complaints were received about the aforementioned vaginal moisturiser and 68 were not dealt with properly.