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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
Drugmakers Sun Pharma and Cipla are recalling products in the US due to manufacturing related issues, according to the US Food and Drug Administration. As per its latest Enforcement Report, the US-based arm of Mumbai-based Sun Pharma is recalling over 26,000 bottles of a generic medication to treat dandruff and skin conditions with inflammation and itching. The Princeton (New Jersey)-based Sun Pharmaceutical Industries Inc is recalling 24,624 bottles of Fluocinolone Acetonide Solution Topical Solution for "Failed Impurities/Degradation Specifications", the US health regulator said. The company initiated the Class III nationwide (US) recall on December 30, 2025. The US Food and Drug Administration (USFDA) noted that the company is also recalling certain batches of a medication to treat acne vulgaris. Sun Pharmaceutical Industries Inc initiated the Class III recall of Clindamycin Phosphate USP on November 26, 2025 due to "Failed Impurities/Degradation: Out of Specification results f