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Amneal Submits Abbreviated New Drug Applications to U.S. FDA for Three Key Complex Generics
- Represents three high-value medicines across complex dosage forms BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal”
About this update from Amneal Pharmaceuticals, Inc.
[{"type":"text","content":"\n- Represents three high-value medicines across complex dosage forms\n\n\n BRIDGEWATER, N.J.--(BUSINESS WIRE)--\nAmneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has submitted Abbreviated New Drug Applications (“ANDA”) to the U.S. Food and Drug Administration (FDA) for three key complex generic products, including:\n\n\n\n\n \n\n\n\n\n\n\n \n\n\n\n\n\n\nProduct\n\n\n\n\n\n\nDosage Category\n\n\n\n\n\n\nU.S. IQVIA sales (TTM May 2023)\n\n\n\n\n\n\n\n\n1\n\n\n\n\n\n\n \n\n\n\n\n\n\nAlbuterol sulfate inhalation\n\n\n\n\n\n\nInhalation\n\n\n\n\n\n\n$814 million\n\n\n\n\n\n\n\n\n2\n\n\n\n\n\n\n \n\n\n\n\n\n\nBimatoprost ophthalmic solution, 0.01%\n\n\n\n\n\n\nOphthalmic\n\n\n\n\n\n\n$779 million\n\n\n\n\n\n\n\n\n3\n\n\n\n\n\n\n \n\n\n\n\n\n\nPropofol emulsion\n\n\n\n\n\n\nInjectable\n\n\n\n\n\n\n$311 million\n\n\n\n\n\n\n\n“We continue to make excellent progress advancing our pipeline of complex, high-value medicines. The filing of applications for three new complex generics are additional proof points in our successful innovation journey. Today, about 90% of our generics R&D pipeline is made up of complex products. As we move up the value chain of product complexity, we are adding new and sustainable long-term growth drivers to our diversified portfolio,” said Chirag and Chintu Patel, Co-Chief Executive Officers.\n\n\nInjectable propofol emulsion, the generic version of Diprivan®, is an IV general anesthetic and sedation drug. Amneal plans to manufacture propofol emulsion internally by leveraging the Company’s global injectables infrastructure. Bimatoprost ophthalmic solution, the generic version of Lumigan®, is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Albuterol sulfate inhalation, the generic version of Proair® HFA, is indicated for the treatment or prevention of bronchospasm related to exercise-induced or reversible obstructive airway disease. All trademarks are the property of their respective owners.\n\n\nAbout Amneal\nAmneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of approximately 270 pharmaceutical products, primarily wit...