The end of the FY saw a bump back up to the 80’s for number of total approvals with 73 “line item” full approval actions and 10 tentative approval actions. What the heck is a “line item” approval action, you may ask? Well, we noticed in September (or perhaps we just missed it in previous […]
The Association for Accessible Medicines released its 2020 Generic Drugs and Biosimilars Access and Savings in the U.S. Report (here) yesterday, outlining the savings that these products brought to American consumers in 2019. “In 2019, according to data provided by IQVIA, U.S. savings from generic drugs added up to $313 billion—including $96 billion and $48.5 […]
Did you ever wonder about the FDA’s requirement than an applicant respond to a complete response letter (CRL) within one year of its issuance as provided for in the regulations at 21 CFR 314.110? Under this regulation, “an applicant must (1) resubmit its ANDA (i.e., submit all materials needed to fully address all deficiencies identified […]
In a drug safety communication on September 23, 2020 titled FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class (here), the FDA announced changes being made to the boxed warning on all benzodiazepine products. The communication describes the need for the change as follows: “[T]o address the serious risks of abuse, […]
The Office of Generic Drugs (OGD) reported some of its official statistics for August today. As usual, the first official reported metrics deal with approval and tentative approval actions, receipt of new ANDAs, and issuance of complete response letters. The OGD reported 58 full-approval actions (which we nailed in our earlier post of unofficial stats […]
The Food and Drug Administration (FDA) is taking final official action withdrawing the approval of two new drug applications for BELVIQ (lorcaserin hydrochloride (HCl)) tablets and BELVIQ XR (lorcaserin HCl) extended-release tablets which were originally approved by FDA on June 27, 2012 and July 15, 2016, respectively. This announcement was made on the Federal Register’s […]
The FDA has been more than busy in its efforts to address the COVID-19 pandemic. Here is an update as of September 11, 2020 regarding some of the statistics the FDA has presented. The FDA has: Authorized 247 tests under emergency use authorizations (EUAs), of these: 197 are molecular tests 46 are antibody tests 4 […]
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In an opinion piece in USA Today (here), eight career executives at the FDA, Patrizia Cavazzoni, Acting Director of the Center for Drug Evaluation and Research, Peter Marks, Director of the Center for Biologics Evaluation and Research, Susan Mayne, Director of the Center for Food Safety and Applied Nutrition, Judy McMeekin, Associate Commissioner for Regulatory […]
Although we were caught off guard by a slightly early update to the July metrics which preceded Official August approval and receipt numbers, we are happy to present them to you at this time. OGD issued 4 refuse-to-receive (RTR) actions and all four were for standard ANDAs. The Agency acknowledged (filed or received, whatever you […]
