Mylan N.V. (NASDAQ:MYL) said it expects to receive a second complete response letter from FDA for an ANDA of a generic version of Advair salmeterol/fluticasone from GlaxoSmithKline plc (NYSE:GSK; LSE:GSK).
Any delay would be a reprieve for GSK, which reported worldwide Advair sales of £3.1 billion ($4.2 billion), including U.S. sales of £1.6B ($2.2 billion), last year.
Mylan said the agency has identified "minor deficiencies." The ANDA has priority designation, which allows approval prior to the standard 90-day time period following the company's response to a CRL, according to Mylan.
At least two other companies have submitted ANDAs to FDA for generic Advair products.
In February, the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) received a CRL from FDA on its ANDA for the generic (see BioCentury Extra, Feb. 8).
On its 1Q18 earnings conference call in April, Novartis CEO Vasant Narasimhan said it plans to conduct a bioequivalence bridging study of the generic and expects to launch next year.
Vectura Group plc (LSE:VEC) and partner Hikma Pharmaceuticals plc (LSE:HIK) received a CRL last year for their Advair generic VR315.
In March, Hikma said FDA is requesting another clinical study, and the company plans to submit the data to FDA "as early as possible" next year with a launch slated for 2020.
Advair comprises an adrenergic receptor beta 2 (ADRB2) agonist (LABA) and a corticosteroid. It is approved for asthma and chronic obstructive pulmonary disease (COPD).
According to Orange Book, most of the patents on Advair aerosol metered dose inhaler are slated to expire this year. The last U.S. patent will expire in 2026.
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