FDA approval for generic Advair Diskus across all strengths, enabling market entry.
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CiplaPrivate▲ Positive
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Cipla Limited has received U.S. FDA approval for its generic version of Advair Diskus across all three strengths. The approval covers 100/50 mcg, 250/50 mcg, and 500/50 mcg doses of the fluticasone propionate and salmeterol inhalation powder, a widely prescribed combination therapy for asthma and COPD. Cipla's product is a therapeutically equivalent, lower-cost alternative in a U.S. market estimated at $908 million according to IQVIA. This marks Cipla's first dry powder inhaler approval from its U.S. manufacturing network, representing a significant milestone in expanding complex respiratory capabilities in the United States. The stock closed Tuesday's trading at INR 1,444.60, up 2.50%.
FDA approval for generic Advair Diskus across all strengths, enabling market entry.