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Recent news about companies that support development of orally inhaled and nasal drug products, including regulatory approvals, new indications for OINDPs and results of clinical studies. 8 APRIL 2020 Inhalation INDUSTRY NEWS FDA requires Boxed Warning for montelukast S I L V E R S P R I N G , M A R Y - LAND— e United States Food and Drug Administration (FDA) announced it is requiring a Boxed Warning for montelukast (Singu- lair ® (Merck) and generics) due to serious behavior and mood-related changes (including the risk of sui- cidal thoughts or actions) that may occur with the asthma and allergy drug. e agency believes that ben- e ts of montelukast may not out- weigh its risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with other medicines. For allergic rhinitis, the FDA has deter- mined that montelukast should be reserved for those patients who are not treated effectively with or cannot tolerate other allergy med- icines. Currently, montelukast prescribing information includes warnings about mental health side e ects, including suicidal thoughts or actions. However, the FDA indi- cated it believes many healthcare professionals, patients and caregiv- ers are not aware of the risk. After conducting an extensive review of available information and con- vening a panel of outside experts, the FDA determined that a Boxed Warningwas appropriate. FDA approves Catalent and Perrigo's generic ProAir ® HFA D U B L I N , I R E L A N D A N D SOMERSET, NEW JERSEY— Catalent Pharma Solutions and Perrigo Company announced that the United States Food and Drug Administration (FDA) has approved their abbreviated new drug application (ANDA) for generic albuterol sulfate inhala- tion aerosol. They stated it is the first AB-rated generic version of ProAir ® HFA (Teva Respiratory, LLC) and the rst generic metered dose inhaler (MDI) to be approved by the FDA since 1996. Generic albuterol sulfate inhalation aerosol is indicated in patients four years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway dis- ease and for the prevention of exer- cise-induced bronchospasm. Teva receives FDA approval of ArmonAir ® Digihaler™ P E T A H T I K V A , I S R A E L — According to Yahoo! Finance, t h e U n i t e d S t a t e s F o o d a n d Drug Administration (FDA) has approved Teva's ArmonAir ® Digi- haler™ (fluticasone propionate) Inhalation Powder, an inhaled cor- ticosteroid delivered by the com- pany's Digihaler™. e device con- tains built-in sensors and connects to a companion mobile applica- tion. ArmonAir Digihaler is indi- cated for the maintenance treat- ment of asthma in patients 12 years and older but is not indicated for relief of acute bronchospasm. e Digihaler portfolio also includes ProAir ® Digihaler™ (albuterol sul- fate 117 mcg) Inhalation Powder and AirDuo ® Digihaler™ ( utica- sone propionate and salmeterol) Inhalation Powder. I N T R O D U C I N G M R X 0 0 6 O P E N - I N H A L E - C L O S E D U A L C AV I T Y F O R T R I P L E T H E R A P Y w w w . m e r x i n . c o m i n f o @ m e r x i n . c o m D e s i g n e d f o r d r u g s t h a t j u s t d o n ' t l i k e e a c h o t h e r. M R X 0 0 6 , o p e n - i n h a l e - c l o s e , d u a l c a v i t y f o r t r i p l e t h e r a p y a c c o m m o d a t e s a c o m b i n a t i o n f o r m u l a t i o n o f 2 o r m o r e A P I s ; u n e q u a l l e d t e c h n o l o g y t a i l o r e d t o c u r r e n t r e g u l a t i o n s a n d h i g h - p e r f o r m a n c e e x p e c t a t i o n s . W E M A K E T H E W O R L D H E A L T H I E R O N E B R E A T H A T A T I M E

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