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Mylan Suffers a Blow as Teva Gets FDA Nod for EpiPen Generic

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Mylan suffered a setback as rival Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) recently won FDA approval for the first generic version of the former’s EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients.

The approval is a significant boost for Teva but the approval will eat into EpiPen sales of Mylan as the generic will obviously be priced lower. Mylan was earlier under the scanner for high price of the product.  We note that Mylan already has its own authorized generic for the same.

Mylan’s stock has lost 10.5% so far this year against the industry’s growth of 4.9%.

 

Meanwhile, Mylan’s second-quarter results were dismal as challenges in North America persist, prompting the management to evaluate strategic alternatives. The company also lowered its outlook as a result of the change in expected complex product launch, utilization assumptions, resizing of product opportunities in the United States, and the negative impact on operations of the restructuring and remediation program in Morgantown.  The generic business in the United States continues to experience pricing and competitive pressure.

The company earlier suffered a setback, when the FDA refused to approve its Abbreviated New Drug Application for the generic version of GlaxoSmithKline’s (GSK - Free Report) asthma drug, Advair Diskus. 

Mylan’s manufacturing partner, Pfizer (PFE - Free Report) earlier experienced interruptions in the production of EpiPen and hence the latter’s supplies to Mylan are inconsistent and inadequate in meeting global demand including the United States.  

Zacks Rank

Mylan currently carries a Zacks Rank #5 (Strong Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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