abbreviated new drug application

The FDA Reauthorization Act of 2017 (FDARA) created a new type of 180-day exclusivity for ANDA applicants applying for approval of certain drugs designated as Competitive Generic Therapies. The FDARA, according to FDA commissioner, Scott Gottlieb, “is part of our broader effort to foster generic competition and help address the high cost of drugs […] key step in making safe and effective generic drugs available to patients quickly and ensuring there’s adequate competition so patients have affordable access to the treatments they need.” Continue Reading Teva Sues FDA Alleging Unlawful Interpretation of the Definition of “First Applicant”

The Food and Drug Administration (FDA), as part of its Drug Competition Action Plan, published a draft guidance detailing good practices for the submission of ANDAs on January 3, 2018. The guidance highlights common, recurring deficiencies that may lead to a delay in the approval of an ANDA and makes recommendations to applicants on how to avoid such deficiencies. A typical ANDA requires an average of four review cycles before approval. The delay happens when ANDAs are submitted without all the information that the FDA needs to determine whether the ANDA meets FDA standards for approval, which leads to additional review cycles. Continue Reading Good ANDA Submission Practices: Summary of Draft Guidance

U.S. Food and Drug Administration (FDA) Commissioner, Dr. Scott Gottlieb, has made generic drugs and drug pricing an agency priority by emphasizing the critical value of generic drugs to public health. In 2017, 1027 total generic drugs were approved, which was the highest number of generic drugs approved in a single year.[1] Table 1 below illustrates 2017 approvals by month. Continue Reading FDA’s Office of Generic Drugs: 2017 Annual Report Highlights