Cipla To Recalibrate US Investments
A More Measured Approach To US Generic R&D And Specialty
Cipla is to moderate investments across its US generics R&D and specialty business, while its India business components – prescription, trade generic and consumer health – are being brought under a “single capital allocation framework.”
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Hikma has received another setback on its US application for a generic version of Advair following a minor complete response letter from the FDA. The resulting delay will push back the expected final response date from the agency closer to that expected by rival Cipla, which filed an ANDA earlier this year.
Shortly after wrapping up a Phase III trial for its proposed generic Advair Diskus product in the US, Cipla has won FDA approval for the first generic Proventil HFA product, as it continues to build up steam in the US respiratory market.
Cipla is celebrating an “important milestone” for the company after the successful completion of a Phase III clinical trial comparing its proposed Advair generic with GSK’s brand in the US. Management has cautioned that approval will be a way off yet, however.