Cipla Receives U.S. FDA Approval for Generic Asthma and COPD Inhaler

Cipla has received approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for the generic version of Advair Diskus (fluticasone propionate and salmeterol inhalation powder), marking a significant milestone in the company’s respiratory portfolio in the United States.

The approval covers all three dosage strengths — 100/50 mcg, 250/50 mcg and 500/50 mcg — and represents the first dry powder inhaler (DPI) approved from Cipla’s U.S.-based manufacturing network.

Commercial Launch Planned in FY27

Cipla said the generic inhaler is expected to be launched in the second quarter of FY27 in the U.S. market.

The approved product is a therapeutically equivalent version of Advair Diskus, a widely prescribed inhalation therapy used for the treatment of asthma and chronic obstructive pulmonary disease (COPD).

According to IQVIA data cited by the company, the U.S. market for fluticasone propionate and salmeterol inhalation powder is valued at approximately $908 million.

Strengthening U.S. Manufacturing Capabilities

Commenting on the approval, Marc Falkin, CEO of Cipla North America, said the milestone reflects the company’s strategic investments in building advanced inhalation manufacturing capabilities in the United States.

He noted that the approval of the first dry powder inhaler from Cipla’s New York manufacturing facility demonstrates the company’s ability to develop and manufacture complex respiratory products locally.

Expanding Access to Complex Therapies

Achin Gupta, Managing Director and Global CEO of Cipla, said the approval reinforces the company’s commitment to improving patient access to complex respiratory therapies in the U.S.

He added that the milestone highlights Cipla’s integrated capabilities in developing, manufacturing and scaling sophisticated inhalation products for global markets.

The approval further strengthens Cipla’s presence in the U.S. pharmaceutical market, particularly in the respiratory care segment, while expanding its portfolio of complex generic medicines.