Hikma Addresses Advair Issues In US
Responds To All Outstanding Questions In The FDA’s CRL
Hikma has submitted a response to the US FDA addressing all outstanding deficiencies in its application for a generic version of GlaxoSmithKline’s Advair Diskus.
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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.
Hikma still sees a substantial opportunity in the generic Advair Diskus market once it makes it to market, according to CEO Siggi Olafsson, while rivals to GSK’s Ellipta range will also be coming into focus several years down the line. Meanwhile, nasal sprays gained through deals with Insys and Glenmark will aid in efforts to differentiate the firm’s non-injectables business in the US.
Company did not kill its development program because of US FDA feedback, but the experience seems to be another lesson in the difficulty in gaining approval for complex generics.