According to Vectura, its partner Hikma Pharmaceuticals has received a complete response letter from the FDA to its ANDA for VR315 fluticasone propionate/salmeterol DPI, a generic version of GSK’s Advair Diskus. Vectura said that the CRL was categorized as “Major” and added, “Based on the initial assessment no material issues were raised regarding the substitutability of the proposed device.”
The company said, “Hikma and Vectura are committed to bringing this important product to the US market and have confidence in the future approval of the program as an AB rated substitutable product” but that it does not anticipate approval of VR 315 in 2017.
In March 2017, the FDA issued a CRL in relation to Mylan’s ANDA for its generic version of Advair Diskus, generating speculation that the CRL was related to the agency’s response to a citizen position from Sandoz regarding bioequivalence testing standards for Advair generics.
Read the Vectura press release.