Teva launches first Truvada and Atripla generics and two digital inhalers

Genéricos/Novedades | Posted 20/11/2020 post-comment0 Post your comment

On 2 October 2020, Teva Pharmaceuticals announced the launch of the first US Food and Drug Administration (FDA) approved generic versions of Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) and Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) tablets for the treatment of HIV-1.

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Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are both combination treatments available as a single pill with similar safety profiles to their reference products.

Brendan O’Grady, Executive Vice President, North America Commercial, Teva said: ‘These products, in addition to our more than 10 HIV-related medications already on the World Health Organization’s Essential Medicines list, represent Teva’s continued pursuit of treatments for HIV to improve health outcomes for the HIV community’.

On 21 September 2020, Teva Respiratory LLC announced the launch of AirDuo Digihaler (fluticasone propionate and salmeterol) inhalation powder and ArmonAir Digihaler (fluticasone propionate) inhalation powder, two digital maintenance inhalers for patients with asthma. AirDuo Digihaler is a prescription medicine used to control asthma symptoms and to prevent symptoms such as wheezing in people 12 years of age and older. ArmonAir Digihaler is a prescription medicine for the long-term treatment of asthma in people 12 years and older. AirDuo Digihaler and ArmonAir Digihaler are not used to relieve sudden breathing problems from asthma and will not replace the need for a rescue inhaler.

The AirDuo Digihaler and ArmonAir Digihaler inhalers automatically detect, record and store inhaler use data, including peak inspiratory flow. Both products can remind patients how often the devices have been used, measure inspiratory flow rates and determine if inhalation technique needs improvement. This usage and inspiratory flow data are then directly sent to the Digihaler app via Bluetooth technology, giving patients the ability to share their data with healthcare providers (HCPs) if they choose to. Access to these data may allow HCPs to make more informed treatment decisions.

AirDuo Digihaler was approved by FDA in July 2019 in a low, medium and high dose (55/14 mcg, 113/14 mcg and 232/14 mcg) and administered as one inhalation twice daily. ArmonAir Digihaler was approved by FDA in February 2020 in a low, medium and high dose (55 mcg, 113 mcg and 232 mcg) and also administered as one inhalation twice daily.

AirDuo Digihaler and ArmonAir Digihaler are part of Teva’s Digihaler portfolio, which also includes ProAir Digihaler, the first and only digital rescue inhaler used to treat or prevent bronchospasm in people with reversible obstructive airway disease, and to prevent exercise-induced bronchospasm. All three products are now commercially available to patients by prescription.

‘The launch of AirDuo Digihaler and ArmonAir Digihaler completes our portfolio of digitally connected inhalers and allows Teva to provide maintenance and rescue digital inhaler options to the US respiratory community, especially in a time when digital health tools are more important than ever’, said Sven Dethlefs, Executive Vice President, Global Marketing & Portfolio, Teva Pharmaceuticals. ‘The full Digihaler family is a major step forward for digital health technologies in helping to transform patient care, and we hope it will enable patients and their healthcare providers to better inform treatment decisions. For Teva, the Digihaler launch is the starting point for new software-based innovations in respiratory, moving treatment options beyond new therapeutic entities’.

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