abstract:Fixed-dose combinations of antiretrovirals are multiple antiretroviral drugs combined into a single pill, which helps reduce pill burden. They may combine different classes of antiretrovirals or contain only a single class.
Ultimately, the biotech hopes the agency will change its interpretation of the law so that drugmakers would be encouraged to develop more fixed-dose combination drugs.
In its petition, the biotech notes that the FDA has denied exclusivity to 10 fixed-dose combination drugs containing both new and previously approved active moieties for nearly 20 years.