Last Updated : Sunday, May 24, 2020 15:03:14

CIPLA files ANDA for inhalation powder form of medicine, to treat asthma

MUMBAI / RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Mumbai headquartered pharmaceutical products manufacturing Indian company Cipla Ltd said of having filed abbreviated new drug application (ANDA) for generic version of Glaxo SmithKline’s Advair Diskus® medicine, which shall be provided in inhalation power form of medicine, for asthma patients.

In a press-release titled, “Cipla files ANDA for generic version of GSK’s Advair Diskus®”, as attached and as enclosed with the regulatory update as submitted by the company to the Indian Bourses, it further read that, Phase-3 clinical study for generic version completed in first attempt and the product aims progresses towards strengthening respiratory franchise in the US market.

The release details further read that, Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as “Cipla”) today announced its submission of an Abbreviated New Drug Application (ANDA) for Fluticasone propionate and Salmeterol inhalation powder (100/50 mcg, 250/50 mcg and 500/50 mcg) to the United States Food and Drug Administration (USFDA).

The Company had recently announced the successful completion of its Phase-3 clinical end-point study for the product in the first attempt.

The product is the generic version of GSK’s Advair Diskus®.

According to IQVIA (IMS Health), Advair Diskus® and its generic equivalents had US sales of approximately US$2.9bn for the 12-month period ending March 2020.

It is indicated as a twice-daily prescription medicine to treat asthma in patients aged four years and older. It is also used in the long term to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups.

According to the IMS study (Dec 2019), Cipla ranked amongst the Top 2 companies globally for DPI and MDI devices.

Cipla’s borderless respiratory program, a slew of new devices launches and the ANDA filing of generic Advair Diskus® are in line with its goal of becoming a global lung leader.

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