乐博现金网登录66866India Pharmaceuticals:FDA defines ways to ease complex generics approval

乐博现金网登录66866India Pharmaceuticals:FDA defines ways to ease complex generics approval

FDA provides ways to ease complex generics approvals: FDA has announced
anew set of policies aimed at easing approvals of complex generic drugs
and initiallyissued two draft guidance documents to support the
development of complex generics.The FDA Commissioner, Scott Gottlieb,
stated in his blog post on 2Oct, 2017that newpolicies are aimed to
provide as much scientific and regulatory clarity as possible
withrespect to complex generics given their increasing significance to
the economic healthof the generic drug industry. Mr Gottlieb further
stated that as part of ongoing broaderefforts, the FDA will work to
develop more tools, methods, and efficient alternativeswherever feasible
for reducing hurdles for complex generics and more guidancedocuments
should be coming in the near-future.。

    What do guidance documents convey? The first draft document reflects
a unifiedapproach to all formal meetings between FDA and ANDA filers for
complex genericsand assists filers in generating and submitting to the
FDA a meeting request (productdevelopment, pre-submission & mid-review
cycle meetings) and the associatedmeeting package. These meetings will
allow for enhanced communication betweenANDA filers and the FDA early in
generic development process, thus allowing moreefficient development,
review and approval pathways. The second draft documentaims to help
submissions of ANDAs for certain specific synthetic peptides,
referencebrands for which are manufactured using rDNA technology.。

    FDA addresses need of the hour for generic industry: Due to
development andregulatory challenges, the complex generic space is
relatively underpenetratedcompared to traditional generics (generic
penetration in key complex drug classese.g. injectables, long-acting
injectables, inhalers etc. range between 8-45%compared to more than 80%
generic penetration in oral solids). A lack of establishedregulatory
pathways has resulted in the entry of only a few players in recent
complexgenerics approvals like gRenvela tab (Aurobindo, Dr Reddy’s),
gLialda (Cadila), andgCopaxone 40mg (Mylan/Natco). Furthermore, only few
players have tried or aretrying to develop generics for upcoming key
opportunities like Advair Diskus,Suboxone Film, NuvaRing, Welchol,
Nasonex, Canasa, etc (Refer page 3for details).Hence, we believe the
FDA’s initiative is the much required move towards addressingthe need of
the industry to drive earnings growth for generic players.。

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