By Michael Erman and Natalie Grover
(Reuters) - Generic drug maker Mylan NV (O:MYL) said on Wednesday it disagrees with the U.S. Food and Drug Administration, which declined to approve Mylan's generic for GlaxoSmithKline Plc's (L:GSK) blockbuster Advair in March.
Mylan President Rajiv Malik said the FDA was asking it to comply with standards set out in draft guidance the agency issued, but that it believes it is not required to do so. An FDA spokeswoman declined to comment, saying she was prohibited by law from discussing a pending application.
Mylan made the comments while reporting first-quarter earnings, in which it flagged declining sales for emergency allergy treatment EpiPen but said it will still meet previously announced earnings targets for the year.
Malik said the company could not comment further on the length of the delay for approval until it meets with the FDA to discuss their disagreement, but that the FDA had designated it as requiring a "major" amendment to its application.
A "major" amendment means a delay of 10-months for an FDA response, Numis analyst Stefan Hamill said in a research note earlier this month about another generic version of Advair from Hikma Pharmaceuticals (L:HIK). It is awaiting an FDA decision by May 10 and analysts on Wednesday said they were now expecting the FDA to also question that application.
Mylan shares fell 0.8 percent to $37.73 in afternoon trading.
The company backed its full year profit and revenue forecast, and reported a first-quarter profit that edged past expectations, helped by demand for products it gained through the acquisition of Swedish drugmaker Meda.
"Our overall expectations for the global pricing environment are unchanged and we are still predicting mid-single digit percentage erosion globally for the year," Malik said.
Mylan has come under fire for sharply increasing the price of EpiPen and classifying the life-saving treatment as a generic rather than a branded product, which led to much smaller rebates to state Medicaid programs.
The company said first-quarter sales of EpiPen in North America declined due to increased competition and the launch of its authorized generic.
Mylan said net income surged to $66.4 million, or 12 cents per share in the first quarter ended March 31, from $13.9 million, or 3 cents per share, a year earlier.
Excluding one-time items, Mylan earned 93 cents per share, beating analysts' average estimate by 1 cent, according to Thomson Reuters I/B/E/S.
Revenue rose 24 percent to $2.72 billion. Analysts on average had expected $2.84 billion.