Mexico’s Health Authority (COFEPRIS) grants marketing authorization for Airflusal® Forspiro®
Approval for 50-100mg, 50-250mg and 50-500mg dosage forms
Product to be branded IrFlosolTM Forspiro® in Mexico
Airflusal® Forspiro® already launched in four European countries as well as in South Korea
Holzkirchen, August 20, 2014 – Sandoz announces today that the Mexican Health Authority (COFEPRIS) has granted Sandoz marketing authorization for Airflusal® Forspiro®, an innovative new inhaler for patients with asthma and/or chronic obstructive pulmonary disease (COPD).
The approval in Mexico is the first in Latin America and follows the marketing authorizations in a total of eight European countries as well as in South Korea. Four European countries have already launched Airflusal® Forspiro® in addition to the launch in May in South Korea. Mexico has approved Airflusal® Forspiro® in the 50-100µg, 50-250µg and 50-500µg dosage forms and the product will be branded IrFlosolTM Forspiro®.
“We look forward to launching Airflusal® Forspiro® in Mexico in the near future and making this important respiratory product available to those suffering from asthma and COPD,” said Jan-Torsten Tews, Sandoz’s Head of Global Respiratory. “Airflusal® Forspiro® is an affordable and award winning new option, developed in close collaboration with patients.”
Airflusal Forspiro offers the proven combination of salmeterol (a long-acting inhaled β2-agonist) and fluticasone propionate (an inhaled corticosteroid) in an innovative new device. The product’s safety, efficacy and equivalence have been proven in multiple clinical trials. It was developed at Aeropharm GmbH in Rudolstadt, Germany, Sandoz’s global respiratory Center of Excellence. Sandoz collaborated with UK-based Vectura, a respiratory product development company, in the design and development. The innovative and intuitive-to-use design of the inhaler was awarded the Red Dot Product Design award in 2011, an internationally recognized quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.
In order to improve patient experience with inhalation devices, Sandoz collaborated closely with patients during the development process. The device includes multiple feedback mechanisms such as visual control features, which help reassure the patient about dosing, a simple lever arm to load the dose, and a clear and accurate dose counter.
Sandoz, the generic pharmaceuticals division of Novartis, is a global leader in the generic pharmaceutical sector. Sandoz employs over 26,500 employees and its products are available in more than 160 countries, offering a broad range of high-quality, affordable products that are no longer protected by patents. With USD 9.2 billion in sales in 2013, Sandoz has a portfolio of approximately 1,100 molecules, and holds the #1 position globally in biosimilars as well as in generic injectables, ophthalmics, dermatology and antibiotics, complemented by leading positions in the cardiovascular, metabolism, central nervous system, pain, gastrointestinal, respiratory, and hormonal therapeutic areas. Sandoz develops, produces, and markets these medicines, as well as active pharmaceutical and biotechnological substances. Nearly half of Sandoz's portfolio is in differentiated products, which are defined as products that are more difficult to scientifically develop and manufacture than standard generics.
In addition to strong organic growth since consolidating its generics businesses under the Sandoz brand name in 2003, Sandoz has benefitted from strong growth of its acquisitions, which include Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US).