Archive · 13 Jan 2026
USFDA Approves Generic Advair for Aurobindo Pharma
The US Food and Drug Administration (USFDA) has approved a generic version of Advair Diskus, a drug used to treat asthma and chronic obstructive pulmonary disease.
Respirent Pharmaceuticals and Lannett received this approval.
Aurobindo Pharma, which is in the process of acquiring Lannett for $250 million, could benefit from this approval.
However, this development is seen as negative for Cipla, which has been waiting for approval of its own generic version of Advair since 2020.
Cipla's potential peak sales from its Advair generic are estimated at $100 million.
The approval increases competition in the market, which could impact Cipla's market share and sales expectations.
USFDA approved generic Advair Diskus for Respirent Pharmaceuticals and Lannett on January 13.
Aurobindo Pharma is acquiring Lannett for $250 million, with the deal expected to close in the next two months.
The approval is positive for Aurobindo Pharma as it could include the newly approved product.
Cipla's own generic version of Advair, filed in 2020, is still awaiting final approval.
Increased competition from the approval is seen as negative for Cipla, potentially impacting its market share and peak sales expectations.
- Who
- Aurobindo Pharma, Cipla, Respirent Pharmaceuticals, Lannett, Viatris (formerly Mylan)
- What
- USFDA approval of generic Advair Diskus
- When
- January 13
- Where
- United States
- Why
- To treat asthma and chronic obstructive pulmonary disease
- Drug
- Advair Diskus
- Generic Equivalent
- Fluticasone Propionate and Salmeterol
- Approval Date
- January 13
- Acquiring Company
- Aurobindo Pharma
- Target Company
- Lannett
- Acquisition Cost
- $250 million
- Expected Acquisition Completion
- Next two months
- Cipla's Peak Sales Estimate
- $100 million