Teva Changes Its Tune On Substitutable Generic Advair

Teva is aggressively developing a fully substitutable generic version of Advair and other AB-rated respiratory products now that FDA has released draft guidance on bioequivalence requirements for the inhaled respiratory drug.

Teva Pharmaceutical Industries Ltd. expects to file regulatory applications for a fully substitutable generic version of GlaxoSmithKline PLC’s top-seller Advair Diskus (fluticasone/salmeterol) in the U.S. and Europe in 2017, positioning the product for launch in 2018, management said during a respiratory-focused R&D presentation Oct. 8.

This is a reversal of Teva’s earlier position on the viability of developing a fully substitutable generic Advair and reflects...

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