FDA Says Mylan's EpiPen Is in Shortage

By Michael Erman

May 10, 2018

(Reuters) - U.S. regulators said on Wednesday that Mylan NV's EpiPen products are in shortage, due to manufacturing delays that are creating intermittent supply constraints of the emergency allergy treatment.

The drugmaker also reported weaker-than-expected first-quarter revenue as sales of the allergy shot declined and the company faced intensifying competition in North America.

Mylan warned U.S. customers on Tuesday that the may have trouble getting EpiPen prescriptions filled due to problems at a factory.

On Wednesday morning, the U.S. Food and Drug Administration added EpiPen, a lower-dose version called EpiPen Jr, and Mylan's own generic versions of those products to its list of drugs in shortage. It said they were currently available, but that "supply levels may vary across wholesalers and pharmacies."

Mylan, which had declined to comment about possible U.S. EpiPen shortages for nearly a month, on Tuesday said it had notified the FDA a few months ago of supply issues due to delays at manufacturing partner Pfizer Inc.

Mylan said it is receiving "continual" supply from Pfizer unit Meridian Medical Technologies, which produces all EpiPens sold globally at a single plant near St. Louis.

Meridian Medical has been hit by a series of manufacturing problems. In March 2017, Mylan recalled tens of thousands of devices after complaints that some had failed to activate and in September it received a warning letter from the FDA.

EARNINGS IN LINE, BUT SALES DIP

Mylan said its net income rose 31 percent to $87.1 million, or 17 cents per share, in the first quarter.

Excluding onetime items, Mylan earned 96 cents per share, matching analysts' expectations.

The company's revenue fell 1.3 percent to $2.68 billion in the three months ended March 31, missing analysts' average expectation of $2.75 billion, according to Thomson Reuters I/B/E/S.

North America sales of Mylan's branded products, including EpiPen, fell $108.7 million.

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