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EAST WINDSOR, N.J. — Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for Aurobindo Receives FDA Approval for roflumilast tablets, 500mcg. Aurobindo Pharma’s Roflumilast Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), DALIRESP Tablets manufactured by Astrazeneca Pharmaceuticals LP.
Roflumilast tablets, are indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
Roflumilast tablets, has an estimated market size of US $170.3 Million for the twelve months ending April 2023, as per IQVIA.
