Federal Register Notices: Week Ending 12/25/2020
The follow are the Federal Register notices published the week ending 12/25/2020:
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Export of Food and Drug Administration-Regulated Products: Export Certificates” (OMB Control Number 0910-0498). To view the notice, click here.
Federal Register notice: FDA is seeking comments on an information collection extension entitled “New Animal Drugs for Investigational Use — 21 CFR Part 511” (OMB Control Number 0910-0117). To view the notice, click here.
Federal Register notice: FDA has determined that Eli Lilly’s Dobutrex (dobutamine hydrochloride) was not withdrawn from sale due to safety or effectiveness concerns. The drug is indicated for when parenteral therapy is necessary for inotropic support in the short-term treatment of adults with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. To view the notice, click here.
Federal Register notice: FDA has announced a 2/2 public meeting entitled “Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials.” The meeting is intended to gather stakeholder input on the scientific and ethical issues that surround the inclusion of pregnant women in clinical trials for drug development. To view the notice, click here.
Federal Register notice: FDA is correcting a 10/9/2020 notice that announced the withdrawal of nine approved ANDAs from multiple applicants. Subsequently, VistaPharm notified the agency that its ANDA for albuterol sulfate syrup should not be withdrawn at this time. To view the notice, click here.
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Orphan Drugs” (OMB Control Number 0910-0167). The collection is being revised to include agency guidance about requesting a meeting, including a teleconference, with FDA on issues related to orphan drug designation requests, humanitarian use device designation requests, rare pediatric disease designation requests, funding opportunities through the Orphan Products Grants Program and the Pediatric Device Consortia Grants Program, and orphan product patient-related topics of concern. To view the notice, click here.
Federal Register notice: FDA has announced the withdrawal of 27 NDAs from multiple applicants after they notified the agency that the products were no longer marketed and requested their withdrawal. To view the notice, click here.
Federal Register notice: FDA is withdrawing approval of an Endo Pharmaceuticals NDA for Opana (oxymorphone hydrochloride) extended-release tablets. The reformulated Opana ER was intended to be resistant to physical and chemical manipulation for abuse by snorting or injecting. Subsequently, FDA determined that data did not show that the product could be expected to meaningfully reduce abuse and declined the company’s request to include labeling describing potentially abuse-deterrent properties. Based on postmarketing data, FDA later observed that there was a significant shift in the route of abuse from nasal to injection following the product’s reformulation. In 2017, FDA requested that Endo remove the drug from the market because its benefits may no longer outweigh its risks due to the potential for abuse. To view the notice, click here.