Johnson & Johnson
The company didn't say why the FDA had turned it down, but did say the agency wasn't requiring any additional clinical studies. It'll work on answering the FDA's questions, and investors probably hope the delay won't be too long.
Paliperidone palmitate seems to be a once-monthly version of Johnson & Johnson's Invega, which has already been approved. Using Elan's
Ironically, one of Johnson & Johnson's other partners may have cheered the FDA's decision. Alkermes
Perhaps the reason Johnson & Johnson is having such bad luck with the FDA is because it keeps trying to get drugs through FDA divisions that, it seems, have cracked down on approvals. A couple of antibiotics have failed to win approval from the agency, and both Eli Lilly's long-lasting injection of Zyprexa and Vanda Pharmaceuticals'
While we can't know exactly what the FDA's problem is, I think the extended-release paliperidone palmitate will eventually be approved. Though the extended wait isn't what Johnson & Johnson had hoped for, given its large, diverse offerings, the temporary rejection shouldn't hurt the company too much.
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