Last week the US FDA announced its intention to strip both Lannett and Mallinckrodt of Abbreviated New Drug Applications (ANDA) covering separate versions of the J&J drug on the basis that neither firm had demonstrated their product’s bioequivalence.
The problem, according to the FDA, is that extended-release Concerta is designed release methylphenidate steadily over a 10 to 12 hour period. Generic versions are required to match that release profile.
The Lannett and Mallinckrodt products deliver drug in the body at a slower rate during the 7- to 12-hour range which the FDA says “may result in patients not having the desired effect.”
The agency – which originally raised concerns about the two generics and asked for data in 2014 – said neither Lannett nor Mallinckrodt have provided the requested information. It also said withdrawal of the ANDAs would prevent the firms from selling their products in the US.
Lannett said it will review the scientific basis of the FDA’s decision to seek ANDA withdrawal and “compile the scientific evidence to convince FDA's Office of Generic Products that our product should continue to be marketed.” The firm has until November 17 to ask for an FDA hearing and December 19 to submit its data.
Bioequivalence questioned
Lannett bought its version of Concerta when it acquired Kremers Urban Pharmaceuticals from Belgian drug firm UCB in 2015.
Originally, UCB had planned to sell Kremers to private equity investors. However, that deal collapsed in December 2014 after the FDA said Kremers version of Concerta was no longer equivalent to the originator and asked the firm to conduct additional studies.
Kremers submitted data from a new bioequivalence study to the FDA in June the following year. Shortly after UCB said it would sell the firm to Lannett for $1.23bn upfront and further payments if the FDA restored the drug’s equivalence rating.
Mallinckrodt has not commented on the FDA’s withdrawal plan.