Looks like there is legislation likely to get approved by October 2011 to allow faster approval of generics. Generics companies will be charged fees, but generics approvals are expected to go from 31 months to 10 months.
Faster FDA reviews of ANDAs are good for the country, but they don’t make much difference for MNTA, specifically.
If enacted by Congress, the law to establish specified review timelines for ANDAs will not be applied retroactively to ANDAs already under review such as NVS/MNTA’s ANDA for Copaxone.
After Copaxone, MNTA does not plan to submit any additional ANDAs. (MNTA’s FoB’s will be submitted to the FDA under the new 351(k) pathway, which is not governed by the pending proposal to speed the review of ANDAs.)
Good point. Still, do we really think the additional resources for generics approvals will *only* go to new ANDA's?
Let's say genericX files today, and tomorrow the legislation is approved. Day after tomorrow genericY files and pays the extra fee. Is genericX really going to still have a 31 month timeline, while genericY gets approved in 10 months?
Maybe. But I would guess (hope) that some of the new resources would also go to clearing the existing backlog (M-Copaxone included) along with speeding new approvals.
Seems like a good news. It is specially good news for the US generic manufacturers.
But given that republicanwhackos are hell bent on destryoying USA last whole decade and transfering all the wealth to China/India for petty gain in their pockets, it is very unlikely that any good bill will pass. Not holding breath.