Fluticasone propionate/Salmeterol xinafoate

(Fluticasone Propionate and Salmeterol Inhalation Powder), across all three strengths MUMBAI, India and WARREN, N.J., July 28, 2026 /PRNewswire/ -- Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) and hereafter referred to as "Cipla") and its wholly owned subsidiary Cipla USA Inc., (hereafter referred to as "Cipla"), today announced that Cipla Limited has received U.S. Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for Generic Advair Diskus® (fluticasone propionate and salmeterol inhalation powder) in all three strengths—100/50 mcg, 250/50 mcg, and 500/50 mcg. The product is a therapeutically equivalent version of Advair Diskus®, a widely prescribed combination therapy indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD). According to IQVIA, the U.S. market for fluticasone propionate and salmeterol inhalation powder is approximately $908 million. This approval represents Cipla's first dry powder inhaler (DPI) approval from its U.S.-based manufacturing network, marking a significant milestone in the company's continued expansion of complex respiratory capabilities in the United States. Commenting on the approval, Achin Gupta, Managing Director & Global CEO, Cipla Limited said, "At Cipla, we're passionate about respiratory care given our long-standing expertise. This approval reinforces our commitment to expanding access to complex therapies in the U.S. and highlights our strength in developing and scaling sophisticated inhalation products through integrated capabilities." Backed by Cipla's vertically integrated inhalation platform, the product reflects the company's commitment to strengthening U.S. manufacturing capabilities for complex respiratory treatments. Marc Falkin, Chief Executive Officer, Cipla North America added, "This approval marks our first dry powder inhaler from our New York facility and reflects our targeted investments in building differentiated inhalation manufacturing capabilities in the U.S. It strengthens our ability to provide reliable, high-quality supply in an important and competitive category." About Cipla Limited Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, antiretroviral, urology, cardiology, anti-infective and CNS segments are well-known. Our 46 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 70+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT Jun'26), 2nd Largest in the pharma prescription market in South Africa (IQVIA MAT May'26), and 2nd largest by prescription in the US Gx (Repulses + MDI) products (IQVIA MAT Jun'26). For nine decades, making a difference to patients has inspired every aspect of Cipla's work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the center of the HIV movement. A responsible corporate citizen, Cipla's humanitarian approach to healthcare in pursuit of its purpose of 'Caring for Life' and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders. For more, please visit , or click on Twitter, Facebook, LinkedIn. Corporate Communications Heena Kanal [email protected] Investor Relations Diksha Maheshwari [email protected] SOURCE Cipla Limited 21% more press release views with Request a Demo

CRYSTAL LAKE, Ill.--(BUSINESS WIRE)--Aptar Digital Health, a global leader in digital health solutions enhancing the patient experience, today announced that the U.S Food and Drug Administration (FDA) has granted 510(k) clearance for HeroTracker® Sense as a Class II medical device. This milestone recognizes HeroTracker® Sense - a Bluetooth-enabled sensor - as an innovative connected add-on for pressurized Metered Dose Inhalers (pMDIs), transforming traditional inhalers into smart, data-driven devices for patients and healthcare professionals. Designed for individuals aged 12 and above, HeroTracker® Sense is compatible with several commonly prescribed asthma and chronic obstructive pulmonary disease (COPD) medications, including Ventolin® HFA, Advair®, and certain albuterol and fluticasone/salmeterol inhalers. Integrated within Aptar Digital Health’s Respiratory Disease Management Platform, HeroTracker® Sense supports users in managing their respiratory health through comprehensive medication and symptom management. The platform delivers real-time usage tracking, personalized reminders and educational resources via an intuitive mobile application, encouraging behavior change and adherence to prescribed therapies. By enabling patients to monitor inhaler techniques and receive instant feedback, the platform aims to support improved respiratory health. “By combining inhalation therapy with advanced digital health solutions, we aim to support patients in improving adherence and providing healthcare professionals with actionable insights,” said Raffi Krikorian, SVP Global Quality and Regulatory Affairs at Aptar Digital Health. “Our platform has previously shown promise in supporting asthma management and reducing reliance on rescue medication1. The FDA's clearance allows us to enable broader access to our connected solutions for patients seeking to better manage their respiratory health.” Asthma remains a significant health concern in the United States, affecting an estimated 26.8 million people across the United States2. It stands among the leading causes of missed school and workdays, contributing to an economic burden of nearly $82 billion each year in medical costs, lost productivity and premature death. With the FDA clearance of HeroTracker® Sense, individuals living with asthma or COPD will now have access to an innovative and user-friendly solution for tracking, evaluating and recording their medication use, aiming to improve treatment outcomes and quality of life. About HeroTracker® Sense HeroTracker® Sense is a connected add-on device attached to a compatible pressurized Metered Dose Inhaler (pMDI) for patients aged 12 and above. It functions as an electronic data capture accessory for monitoring and recording individual inhalation actuation, shake, orientation, coordination, and inspiratory strength and duration during prescribed inhaler use. HeroTracker® Sense is designed to operate with specific pMDI and medication indicated on the label. It does not provide information on the remaining quantity of medication in the inhaler and does not include a dose-counting function. HeroTracker® Sense does not provide spirometry measurements. HeroTracker® Sense may be used in clinical practice or clinical trials, where specialists require insights into whether a patient has used their prescribed medication or to assess inhalation technique. About Aptar Digital Health Aptar Pharma's Digital Health division is part of AptarGroup, Inc. (NYSE:ATR), a global leader in drug and consumer product dosing, dispensing and protection technologies. Aptar Digital Health creates end-to-end solutions to enhance patient experiences every day, leveraging a holistic ecosystem of digital interventions. Amplified by an industry-leading portfolio of products and solutions, Aptar Digital Health’s offering combines mobile and web apps, Software-as-Medical-Device, connected drug delivery systems, advanced data analysis services, and patient onboarding and training solutions to actively empower patients and create a positive treatment journey. Aptar is headquartered in Crystal Lake, Illinois and has more than 13,000 dedicated employees in 20 countries. For more information, visit www.aptardigitalhealth.com and www.aptar.com. 1 Bijlani A, Mauger D, Goodheart C, dOrsay G, Suman J. Impact of a digital therapeutic on adult asthma. Eur J Public Health. 2023 Oct 24;33(Suppl 2):ckad160.823. doi: 10.1093/eurpub/ckad160.823. PMCID: PMC10597004. 2 Most Recent National Asthma Data | CDC