Last week, Johnson & Johnson caught a break when the FDA kicked a pair of controversial copies of its ADHD med Concerta off the market. Now, there’s a new challenger stepping up to the plate, though--and that’s Mylan.
Generics of Johnson & Johnson’s ADHD pill Concerta are hitting hard times due to an FDA crackdown on their bioequivalence. The agency said six months ago that generics makers Lannett and Mallinckrodt had that much time to confirm their extended-release technology matched that of J&J’s.
The message is clear for drugmakers these days: Don’t risk conspicuous price increases. Whether it’s one big jack-up or a series of smaller ones, you’ll get some unwanted attention. Lannett, Ariad and Novum apparently didn't get the memo.
The regulatory problems of a Chinese API maker have created issues for U.S. drugmaker Lannett, resulting in the withdrawal of an approval for a chemo drug. But instead of suing its API partner, Lannett has sued the FDA.