The U.S. Food and Drug Administration today approved the first generic of ProAir HFA Inhalation Aerosol for the treatment or prevention of bronchospasm in patients four years of age and older with reversible obstructive airway disease and the prevention of exercise-induced bronchospasm in patients four years of age and older.
"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, M.D. "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. As a result, too many complex drugs lack generic competition even after patents and exclusivities no longer block generic approval. Supporting development and approval of generic copies of these complex medicines so that these products can get to patients has been a major focus of our efforts to improve competition and access and to lower drug prices. Getting more generic copies of complex drugs to the market is a key priority for how we'll help bring new savings to consumers."
According to the National Heart, Lung, and Blood Institute, bronchospasms occur when the muscles surrounding the airways swell and tighten, squeezing the airways and making them smaller. Exercise and other physical activity can bring on symptoms in most people who have asthma and may occur either during or right after being active. Asthma causes recurring periods of wheezing (a whistling sound when breathing), chest tightness, shortness of breath and coughing. The coughing often worsens at night or early in the morning. Asthma affects people of all ages, but it most often starts during childhood. In the United States, more than 26 million people are known to have asthma, about 7 million of these people are children.
The most common side effects associated with Albuterol Sulfate Inhalation Aerosol are headache, rapid heart rate (tachycardia), pain, dizziness, sore throat (pharyngitis), rhinitis, chest pain, palpitations, tremor and nervousness.
The FDA regularly takes steps to help guide industry through the development process for generic drug products, including combination products, such as metered dose inhalers, that consist of a drug and a device. The development of generic combination products can be more challenging than solid oral dosage forms, like tablets.
Under the Generic Drug User Fee Amendments (GDUFA), individual companies can meet with the FDA as part of its pre-Abbreviated New Drug Application (ANDA) program to support the development of such complex generic drug products. The FDA also publishes guidance documents describing the steps the FDA recommends companies take to submit complete applications for generic drug products.
In 2016, the FDA issued a revised draft product-specific guidance for proposed generic albuterol sulfate metered dose inhalers, including drug products referencing ProAir HFA. Among other things, the draft guidance provides bioequivalence recommendations.
The FDA requires sponsors to submit appropriate data and information to demonstrate that complex generic drug-device combination products meet the agency's rigorous approval standards. These standards ensure that quality generic drug products are as safe and effective as their brand name counterparts.
In 2020, the FDA will continue to advance additional policies to promote generic competition for complex generic drug products. Among other steps, the agency intends to publish additional guidance documents to aid in the development of specific complex generic drug products. The FDA also plans to publish a series of guidances to address regulatory and scientific challenges that make it generally more difficult to develop complex generic drug products because of their complex formulation or mode of delivery. As part of this, the FDA intends to issue draft guidance with recommendations on establishing active ingredient sameness. In addition, the FDA is going to help advance the development of new analytical tools and in vitro tests that may provide additional accurate, sensitive and reproducible ways to support development of complex generic drugs. Better tools can reduce complex generic drug development time and cost and can inform regulatory decisions.
Addressing the challenges related to complex generics, and promoting more generic competition to these medicines, is a key part of the FDA's Drug Competition Action Plan, and the agency's efforts to promote patient access and more affordable medicines.
The FDA granted approval of this generic albuterol sulfate inhalation aerosol to Perrigo Pharmaceutical Co.
Media Contact: Jim McKinney, 240-328-7305Consumer Inquiries: 888-INFO-FDA
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
SOURCE U.S. Food and Drug Administration
美国食品药品监督管理局（Food and Drug Administration）今天批准了第一个仿制药的 ProAir HFA 吸入气雾剂，用于治疗或预防4岁及以上可逆性阻塞性气道疾病患者的支气管痉挛，以及预防4岁及以上患者的运动性支气管痉挛。
“今天批准了美国最常用的救援吸气器之一的第一个仿制药产品，这是我们长期承诺的一部分，即推动患者获得低成本、高质量的仿制药产品，这些产品与他们的品牌同行一样安全有效。FDA 专员 StephenM.Hahn 医学博士（M.D.）博士说："这种计量吸入器被称为复杂仿制药，由于其配方复杂或交货方式复杂，传统上难以复制。因此，即使在专利和排他性不再阻碍仿制药批准之后，太多的复杂药物也缺乏仿制药竞争。支持开发和批准这些复杂药物的仿制药，以使这些产品能够提供给患者，一直是我们努力改善竞争和获取途径以及降低药品价格的主要重点。让更多的仿制药进入市场是我们如何为消费者带来新的节省的一个关键优先事项。”
根据仿制药用户费用修正案（ GDUFA ），个别公司可以与 FDA 会面，作为其前期简略新药申请（ ANDA ）计划的一部分，以支持此类复杂仿制药产品的开发。FDA 还发布指导文件，说明 FDA 建议公司采取的步骤，提交完整的仿制药产品申请。
2016年， FDA 发布了针对拟议的仿制药硫酸阿尔伯特罗计量吸入器的产品特定指南草案修订稿，包括参考 ProAir HFA 的药品产品。除其他外，指南草案提供了生物等效性建议。
FDA 要求赞助商提交适当的数据和信息，以证明复杂的仿制药-器械组合产品符合 FDA 严格的审批标准。这些标准确保高质量的仿制药产品与其品牌同行一样安全有效。
2020年， FDA 将继续推进其他政策，促进复杂仿制药产品的仿制药竞争。除其他步骤外，该机构打算发布更多指导文件，以帮助开发具体的复杂仿制药产品。FDA 还计划发布一系列指南，以应对监管和科学方面的挑战，这些挑战使得开发复杂的仿制药产品由于其复杂的制剂或交付模式而变得更加困难。作为这一工作的一部分， FDA 打算发布指南草案，建议建立有效成分一致性。此外， FDA 还将帮助推进新的分析工具和体外试验的开发，以提供更多准确、敏感和可重复的方式来支持复杂仿制药的开发。更好的工具可以减少复杂的仿制药开发时间和成本，并能为监管决策提供信息。
应对与复杂仿制药相关的挑战，促进对这些药物的更多仿制药竞争，是 FDA 药品竞争行动计划的关键部分，也是 FDA 促进患者获得更多廉价药品的努力。
FDA 批准了该仿制药硫酸阿尔伯特罗吸入气雾剂给 Perrigo 制药公司。
媒体联系人： Jim McKinney ，240-328-7305消费者查询：888-INFO-FDA
美国食品药品监督管理局（Food and Drug Administration）