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Pharma major Cipla Ltd on Thursday said it has received final approval from the US health regulator for its generic version of albuterol sulfate inhalation aerosol indicated for the treatment or prevention of bronchospasm. The final approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Albuterol sulfate inhalation aerosol of strength 90 mcg per actuation, Cipla said in a regulatory filing. It is the first AB-rated generic therapeutic equivalent of Ventolin HFA, marketed by GlaxoSmithKline, it added. Commenting on the approval, Cipla Managing Director and Global CEO Achin Gupta said, "This marks an important milestone for Cipla and reflects our strong scientific and regulatory capabilities in complex inhalation products." He further said, "Lung health remains at the heart of all our offerings and follows a singular, distilled objective, to build a sustainable and differentiated portfolio for patients globally." Albuter
AstraZeneca India on Tuesday said it will set up five centres across Delhi, Ahmedabad, Goa and Cochin to provide a systematic approach to standardised management of patients with severe asthma. The Centers of Excellence (COEs) would concentrate on specialty and clinical assessment, diagnosis, patient counselling, biologics initiation, and data management related to severe asthma, the drug firm said in a statement. "In India, severe asthma is largely managed by oral glucocorticoids that have side effects such as osteoporosis, hypertension, ulcers, weight gain, etc., despite availability of newer treatment options such as biologicals that have shown to improve outcomes in patients," AstraZeneca India Vice President - Medical Affairs & Regulatory Anil Kukreja said. The company's goal is to establish more such centres of excellence throughout the country and tackle complications by continually monitoring patients, educating healthcare professionals and improving respiratory health for
Moderate levels of two outdoor air pollutants, ozone and fine particulate matter, are associated with non-viral asthma attacks in children and adolescents who live in low-income urban areas, a study conducted in the US has found. The study also identifies associations between exposure to the two pollutants and molecular changes in the children's airways during non-viral asthma attacks, suggesting potential mechanisms for those attacks. The observational study, funded by the National Institutes of Health (NIH), US, is one of the first to link elevated levels of specific outdoor air pollutants in particular urban locations to distinct changes in the airways during asthma attacks not triggered by respiratory viruses, according to the investigators. The findings are published in the journal The Lancet Planetary Health. "The strong association this study demonstrates between specific air pollutants among children in impoverished urban communities and non-viral asthma attacks further ...
Pharmaceuticals firm Lupin Ltd on Thursday said it has launched a fixed-dose triple drug combination of Indacaterol, Glycopyrronium and Mometasone for managing asthma. The product launched under the brand name DIFIZMA is being offered as a dry powder inhalation, the company said in a regulatory filing. "DIFIZMA is the only FDC (fixed-dose combination) that has been approved by the Drug Controller General of India (DCGI) for the treatment of inadequately controlled asthma," it said. The product will help in the management of inadequately controlled asthma by improving lung function, providing better symptom control and reducing exacerbations. The drug will be available in one strength with a fixed-dose to be taken once daily, the company added. Lupin India Region Formulations President Rajeev Sibal claimed that DIFIZMA is a first-of-its-kind novel combination product available in India. It is aimed at catering to the unmet need of patients with inadequately controlled asthma and al