Teva Advancing Two Advair Generics With Late 2017 Target
Teva will move forward an internal generic Advair candidate and one acquired from Allergan to improve its chances of getting an interchangeable version of the market-leading asthma drug approved by FDA.
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US FDA approves Teva’s fluticasone/salmeterol fixed-dose combination product under the 505(b)(2) NDA route with an asthma indication but no labeling claim for chronic obstructive pulmonary disease.
Six pharma deals announced thus far in 2016 carried up-front values of $1 billion or more, down considerably from the high-volume, high-value M&A industry experienced the prior two years. Pharma manufacturers appear to be recalibrating – digesting previous acquisitions, adjusting to new biotech valuations and taking stock of the political and macro-economic climate – but fundamentals suggest pharma dealmaking will pick up. Pfizer’s $14 billion offer for Medivation might represent a turning point.
President Rajiv Malik said there has been “huge movement” at the agency around executing on the first ANDA for a generic version of GlaxoSmithKline’s blockbuster Advair.