FDA Approves First Advair Diskus Generic

JANUARY 30, 2019
Kevin Kunzmann
FDAThe US Food and Drug Administration (FDA) has approved the first generic for fluticasone propionate and salmeterol inhalation powder (Advair Diskus) for patients aged 4 years and older with either asthma or chronic obstructive pulmonary disease (COPD).

The Mylan-based generic, now approved for the twice-daily treatment of asthma or airflow obstruction management and exacerbation reduction of COPD, will be available as an inhaler in 3 different strengths:
  • fluticasone propionate 100 mcg/ salmeterol 50 mcg
  • fluticasone propionate 250 mcg/ salmeterol 50 mcg
  • fluticasone propionate 500 mcg/ salmeterol 50 mcg

The approval comes 7 months after Mylan received a Complete Response Letter (CRL) for a generic Advair Diskus inhaler. The generic’s abbreviated new drug application (ANDA) was originally submitted to the FDA in December 2015.

Advair Diskus, from GlaxoSmithKline, lost US patent protection in 2010. With the first generic product available for one of the country’s most popular inhaler therapies is part of the FDA’s “longstanding commitment to advance access to lower cost, high quality generic alternatives,” Janet Woodcock, MD, FDA Center for Drug Evaluation and Research director, said in a statement.

“People living with asthma and COPD know too well the critical importance of having access to the treatment they need to feel better,” Woodcock said. “Today’s approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug.”

The FDA currently requires manufacturers provide appropriate data and information displaying complex generic drug-device combination products meet expectations and standards for efficacy and safety as their brand-name counterparts.

Anna Abram, FDA Deputy Commissioner for Policy, Planning, Legislation and Analysis acknowledged this expectation as a challenge for companies producing for generics, noting the administration is committed to advancing guidance for companies in order to optimize more complex generic products. She added the FDA is also prioritizing review of applications “covering proposed generic complex products for which a generic has not yet been approved.”

Common side effects associated with the inhaler therapy for asthma care include upper respiratory tract infection or inflammation, pharyngitis, dysphonia, and bronchitis, among others. For treatment and management of COPD, common effects include pneumonia, oral candidiasis, and throat irritation, among others.

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