The most frequent adverse effects associated with albuterol sulfate inhalation aerosol are headache, rapid heart rate, pain, dizziness, sore throat, rhinitis, chest pain, palpitations, tremor, and nervousness.See how you can participate in the APhA2021 program.© Copyright 2020, American Pharmacists Association All Rights Reserved. 12-01101 (consolidated)]. This approval and first-to-market generic launch is another vivid example of our team’s commitment and ability to bring new specialized products to market that lower costs for consumers and payors.”“This is a significant technical achievement for both parties, as it is the first generic Metered-Dose Inhaler to be approved by the FDA in over twenty years,” commented Jonathan Arnold, president, Oral and Specialty Delivery at Catalent. With respect to 180-day generic drug exclusivity, we note that Perrigo was the first ANDA applicant for Albuterol Sulfate Inhalation Aerosol, 90 mcg (base)/actuation, to Web design and development: DUBLIN – Perrigo and its partner, Catalent Pharma Solutions, Wednesday announced that the U.S. Food and Drug Administration (FDA) has approved Perrigo’s abbreviated new drug application for generic albuterol sulfate inhalation aerosol, the first AB-rated generic version of ProAir HFA. Letters, Reviews, Labels, Patient Package Insert Notes Url; 02/24/2020: ORIG-1: Approval Letter (PDF) Label is not available on this site. Anyone else out there having issues with the new generic albuterol inhaler made by Perrigo? © 2020 Chain Drug Review, 126 Fifth Avenue, New York, New York 10011 | Tel: 212-213-6000 | email: 50. “The approval also highlights Catalent’s commercial manufacturing capability and complements the extensive product development and clinical-scale production capabilities at our North Carolina facility for Metered-Dose and Dry Powder Inhalers, and unit/bi-dose nasal drug-device combination products.” Consumer ratings and reviews for ALBUTEROL SULFATE. FDA on Monday approved the first generic of albuterol sulfate (ProAir HFA) inhalation aerosol. FDA on Monday approved the first generic of albuterol sulfate (ProAir HFA) inhalation aerosol. Perrigo is launching a limited quantity of generic albuterol sulfate inhalation aerosol and, in collaboration with its development and manufacturing partner Catalent, is ramping up production to meet future demand. You have also notified the Agency that this case was dismissed. "Metered dose inhalers like these are known as complex generics, which are traditionally harder to copy because of their complex formulation or mode of delivery." "Today's approval of the first generic drug product for one of the most commonly used rescue inhalers in the U.S. is part of our longstanding commitment to advance patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts, and to expand opportunities to bring generic copies of complex drugs to the market," said FDA Commissioner Stephen M. Hahn, MD. Posted by 3 months ago. The approval, awarded to Perrigo Pharmaceutical Co., is for the treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease and the prevention of exercise-induced bronchospasm in patients aged 4 years and older. Perrigo and its partner, Catalent Pharma Solutions, Wednesday announced that the U.S. Food and Drug Administration (FDA) has approved Perrigo’s abbreviated new drug application for generic albuterol sulfate inhalation aerosol, the first AB-rated generic version of ProAir HFA. If your State License number is … Includes 9 patient ratings with average score of 3.0, comments, side effects, dosage, sex, age, time taken. Perrigo executive vice president and president, Rx Pharmaceuticals, Sharon Kochan stated, “Achieving FDA approval of this complex generic product was the outcome of an industry-leading collaboration in product development and regulatory expertise between Perrigo and Catalent that spanned over a decade.