Cipla receives final approval for generic version of Sunovion Pharmaceuticals, Inc.'s Brovana® (Arformoterol Tartrate Inhalation Solution 15 mcg/ 2mL)

News provided by

Cipla

23 Jun, 2021, 07:00 ET

MUMBAI, India, June 23, 2021 /PRNewswire/ -- Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) (hereafter referred to as "Cipla") today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Arformoterol Tartrate Inhalation Solution 15 mcg / 2 mL from the United States Food and Drug Administration (US FDA).

Cipla's Arformoterol Tartrate Inhalation Solution 15 mcg / 2 mL is AN-rated generic therapeutic equivalent version of Sunovion Pharmaceuticals Inc.'s Brovana®.

Brovana® is a long-acting beta-2 adrenergic agonist (beta-2 agonist) indicated for:

  • Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

According to IQVIA (IMS Health), Brovana® had US sales of approximately $438M for the 12-month period ending April 2021.

The product is available for shipping immediately.

About Cipla:

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, anti-retroviral, 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 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT April' 21), 3rd largest in the pharma private market in South Africa (IQVIA MAT April'21), and is among the most dispensed generic players in the U.S. For over eight 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 centre 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 www.cipla.com, or click on Twitter, Facebook, LinkedIn.

For queries, please contact:

Corporate Communications
Heena Kanal
E-Mail: [email protected]  

Investor Relations
Naveen Bansal
E-Mail: [email protected]

SOURCE Cipla

Also from this source

Investissement annoncé de 15 millions d'euros par Cipla EU dans Ethris, initiant une collaboration stratégique

Cipla EU invertirá 15 millones de euros en Ethris, iniciando una colaboración estratégica

Explore

More news releases in similar topics

PRN Top Stories Newsletters

Sign up to get PRN’s top stories and curated news delivered to your inbox weekly!

Thank you for subscribing!

By signing up you agree to receive content from us.
Our newsletters contain tracking pixels to help us deliver unique content based on each subscriber's engagement and interests. For more information on how we will use your data to ensure we send you relevant content please visit our PRN Consumer Newsletter Privacy Notice. You can withdraw your consent at any time in the footer of every email you'll receive. Mit Ihrer Anmeldung erklären Sie sich damit einverstanden, Inhalte von uns zu erhalten.
Unsere Newsletter enthalten Zählpixel, die die Lieferung einzigartiger Inhalte in Bezug auf das Abonnement und die Interessen der einzelnen Abonnenten ermöglichen. Weitere Informationen über die Verwendung Ihrer Daten im Hinblick auf die Zusendung von relevanten Inhalten, finden Sie in unserer PRN Consumer Newsletter Privacy Notice. Ihre Zustimmung können Sie jederzeit in der Fußzeile jeder erhaltenen E-Mail widerrufen. En vous inscrivant à la newsletter, vous consentez à la réception de contenus de notre part.
Notre newsletter contient des pixels espions nous permettant la fourniture à chaque abonné, d’un contenu unique en lien avec ses souscriptions et intérêts. Pour de plus amples informations sur l’utilisation faite de vos données en vue de l’envoi des contenus concernés, nous vous invitons à consulter la politique de confidentialité disponible à partir du lien suivant PRN Consumer Newsletter Privacy Notice. Vous pouvez à tout moment revenir sur votre consentement par le biais des informations situées au bas de chaque e-mail reçu. Регистрирайки се, Вие се съгласявате да получавате информационно съдържание от нас. Нашите бюлетини съдържат проследяващи пиксели, които ни помагат да предоставяме уникално съдържание въз основа на ангажираността и интересите на всеки абонат. За повече информация относно начина, по който ще използваме Вашите данни, за да гарантираме, че Ви изпращаме подходящо съдържание, моля, направете справка с нашето Уведомление за поверителност на потребителския бюлетин на PRN. Можете да оттеглите съгласието си по всяко време в долния колонтитул на всеки от имейлите, които ще получите.