Mylan's Generic Version Of Advair Diskus Wins FDA Approval

Mylan N.V. (NASDAQ:MYL) received a significant boost when the FDA approved its generic version of GlaxoSmithKline’s (NYSE:GSK) Advair Diskus — Wixela Inhub — following a few setbacks.

Notably, this is the first generic of Advair Diskus approved, which in turn, will give Mylan an edge in the market.

Wixela Inhub is indicated for the twice-daily treatment of asthma patients aged four and above, who are not adequately relieved by long-term asthma-control medications or whose disease warrants initiation of therapy with both inhaled corticosteroids and long-acting beta agonists; maintenance treatment of chronic obstructive pulmonary disease (COPD) and the reduction of COPD exacerbations in patients with a history of exacerbations.

The generic will be launched in the second half of this month and will incorporate the latest safety information required by the FDA earlier in January, which prompted an amendment to the label for certain inhaled corticosteroids including Advair Diskus and any generic version.

The news should please investors as the regulatory agency had earlier issued a complete response letter (CRL) to Mylan’s Abbreviated New Drug Application (ANDA) for the generic version of Advair Diskus citing minor deficiencies.

The nod will be a great boost to Mylan’s generic portfolio given the market potential. Per Iqvia, Advair Diskus registered sales of $4.2 billion for the 12 months ending November 30, 2018.

Since Wixela Inhub is the first generic to be approved, it will surely gain advantage in the market. We remind investors that Novartis’ (NYSE:NVS) generic arm, Sandoz, is also developing a generic version of Advair Diskus. Incidentally, Sandoz too was issued a CRL for its generic version.

Meanwhile, sales of Glaxo’s Advair will take a hit with a cheaper generic available in the market now.

Mylan’s stock has lost 18.3% in the last six months compared with the industry’s decline of 14.5%. Mylan’s portfolio of generics has been facing challenges of late.

Mylan proactively discontinued a number of products while also transferring some to other sites. These strategic moves have caused a temporary disruption in the supply of certain products and also lowered volumes of North America generic sales.

Zacks Rank & Key Pick

Mylan currently carries a Zacks Rank #3 (Hold). Mallinckrodt plc (NYSE:MNK) is a better-ranked stock in the health care space, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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