Ipratropium Bromide Nasal Solution is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals
This product will be manufactured at Lupin’s Pithampur facility in India
Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients
This collaboration marks a significant milestone in countering the disease burden by enhancing access to products for patients in the US
Lupin actively contributes to alleviating the burden of COPD for patients across the nation
This product will be manufactured at Lupin's Pithampur facility in India
The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial
Boehringer Ingelheim plans to study this novel investigational therapy in patients with progressive fibrosing interstitial lung diseases
The designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with a preserved ejection fraction
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