Issue link: http://www.e-digitaleditions.com/i/880535
8 OctOber 2017 Inhalation (beclomethasone dipropionate H F A ) i n h a l a t i o n a e r o s o l , a breath-actuated inhaler for the maintenance treatment of asthma a s a p r o p h y l a c t i c t h e r a p y i n patients four years of age and older. It is not indicated for the relief of acute bronchospasm. e product is expected to become commer- cially available in both 40 mcg and 80 mcg by prescription during the f i r s t q u a r t e r o f 2 0 1 8 . A s a breath-actuated metered dose inhaler (MDI), QVAR RediHaler will eliminate the need for hand/ breath coordination during inhala- tion. It is also designed for use without shaking or priming and should not be used with a spacer or valved holding chamber. Upon launch of the breath-actuated form of QVAR, Teva plans to discon- tinue sales of its currently available form, QVAR MDI with dose counter, originally approved by the FDA in 2014. Propeller Health and GSK expand collaboration MADISON, WISCONSIN— Propeller Health has announced expansion of its 2015 collaboration with GSK, enabling both compa- nies to prepare for and undertake commercial activities using the Pro- peller clip-on sensor and software platform for use with GSK's Ellipta inhaler. For the first time, the Pro- peller technology for the Ellipta inhaler will be part of commercial pilots with GSK outside the United States, explained David Van Sickle, CEO and co-founder of Propeller. e announcement follows success- ful CE marking and US Food and D r u g A d m i n i s t r a t i o n ( F D A ) 510(k) class II clearance of the Pro- peller sensor and software program for the Ellipta inhaler in late 2016. The sensor automatically records medication use, which the software analyzes and presents to patients and physicians, giving an in-depth view into adherence. e Propeller platform is compatible with the majority of common asthma and COPD inhaler devices and has been used in more than 55 commercial programs in the US. have exclusive license to prioritize a c c e s s t o D e l t y b a i n S o u t h Africa and India, which the World Health Organization (WHO) regards among the highest-burden countries for MDR-TB and TB/ H I V c o - i n f e c t i o n , w i t h o v e r 150,000 estimated new cases of MDR-TB/rifampicin-resistant TB in 2015. Mylan is expected to exer- cise its rights in additional high MDR-TB burden countries where Otsuka does not have a commercial presence. Deltyba is one of two a n t i - t u b e r c u l o s i s m e d i c i n e s recently approved, after more than 40 years of treatment with the same a g e n t s . S i n c e i t s r e g u l a t o r y approval, more than 4,000 treat- ment courses have been shipped for use in more than 50 countries. Teva receives FDA approval of breath-actuated QVAR ® RediHaler™ JERUSALEM, ISRAEL—Accord- ing to Business Wire, Teva Pharma- c e u t i c a l I n d u s t r i e s L t d . h a s announced approval by the US Food and Drug Administration (FDA) of QVAR ® RediHaler TM