Amneal Submits ANDAs to FDA for Three Key Complex Generics Amneal Pharmaceuticals, Inc. announced it has submitted Abbreviated New Drug Applications (“ANDA”) to the FDA for three key complex generic products, including:
"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.
Injectable 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.
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