http://www.fda.gov/ en http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc. Tue, 01 Aug 2023 16:13:59 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs http://www.fda.gov/drugs/drug-safety-and-availability/drug-alerts-and-statements FDA Drug Alerts and Statements Tue, 01 Aug 2023 16:08:16 EDT FDA http://www.fda.gov/drugs/drug-safety-and-availability/drug-alerts-and-statements http://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD) Tue, 01 Aug 2023 15:57:43 EDT FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files http://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/transcript-improving-regulatory-communication-cder-nextgen-portal-december-19-2019-issue "Improving Regulatory Communication via the CDER NextGen Portal" December 19, 2019 Issue  Tue, 01 Aug 2023 14:38:14 EDT FDA http://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/transcript-improving-regulatory-communication-cder-nextgen-portal-december-19-2019-issue http://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/transcript-abbreviated-approval-pathways-drug-product-505b2-or-anda-september-19-2019-issue "Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA?" September 19, 2019 Issue Tue, 01 Aug 2023 14:35:20 EDT FDA http://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/transcript-abbreviated-approval-pathways-drug-product-505b2-or-anda-september-19-2019-issue http://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments FDA is soliciting general comments on GDUFA II Program Fee: List of Abbreviated New Drug Application Sponsors and Application Numbers. The information gathered from public comments will assist FDA in accurately assessing FY 2018 GDUFA Program Fees in a timely manner. FDA has begun an inventory of Tue, 01 Aug 2023 14:10:39 EDT FDA http://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drugs-program-monthly-and-quarterly-activities-report Monthly and quarterly metrics of the FDA Generic Drugs Program. Tue, 01 Aug 2023 13:23:14 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drugs-program-monthly-and-quarterly-activities-report http://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-shortage-adderall FDA posted a shortage of the immediate release formulation of amphetamine mixed salts, commonly referred to by the brand name Adderall or Adderall IR. Tue, 01 Aug 2023 12:47:58 EDT FDA http://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-shortage-adderall http://www.fda.gov/drugs/drug-shortages/drug-shortages-additional-news-and-information Drug Shortages: Additional News and Information Tue, 01 Aug 2023 12:35:48 EDT FDA http://www.fda.gov/drugs/drug-shortages/drug-shortages-additional-news-and-information http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mylan-laboratories-limited-unit-8-viatris-company-589297-07272023 CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Tue, 01 Aug 2023 12:22:10 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mylan-laboratories-limited-unit-8-viatris-company-589297-07272023 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mylan-laboratories-limited-589297-unit-8 CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Tue, 01 Aug 2023 12:21:39 EDT Center for Drug Evaluation and Research http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mylan-laboratories-limited-589297-unit-8 http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall-2-lots-tydemytm-drospirenone-ethinyl Lupin Pharmaceuticals Inc. (Lupin) is voluntarily recalling two (2) lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg) to the patient (consumer/user) level due to out of specification (OOS) test results at t Tue, 01 Aug 2023 12:17:54 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall-2-lots-tydemytm-drospirenone-ethinyl http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/muscle-sports-products-llc-625731-09232022 Unapproved New Drugs/Misbranded Tue, 01 Aug 2023 11:58:53 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/muscle-sports-products-llc-625731-09232022 http://www.fda.gov/drugs/special-features/high-blood-pressure-understanding-silent-killer High blood pressure is known as the silent killer. There are often no symptoms until the heart, arteries, and other organs are already damaged. Tue, 01 Aug 2023 11:32:44 EDT FDA http://www.fda.gov/drugs/special-features/high-blood-pressure-understanding-silent-killer http://www.fda.gov/news-events/press-announcements/fda-approves-second-over-counter-naloxone-nasal-spray-product The U.S. Food and Drug Administration approved the second naloxone nasal spray product available without a prescription. Tue, 01 Aug 2023 11:22:14 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-second-over-counter-naloxone-nasal-spray-product http://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individua Tue, 01 Aug 2023 11:06:01 EDT FDA http://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-652067-07282023 CGMP/Finished Pharmaceuticals/Adulterated Tue, 01 Aug 2023 10:31:02 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-652067-07282023 http://www.fda.gov/industry/fda-user-fee-programs/human-drug-compounding-outsourcing-facility-fees Human Drug Compounding Outsourcing Facility Fees Tue, 01 Aug 2023 10:27:15 EDT FDA http://www.fda.gov/industry/fda-user-fee-programs/human-drug-compounding-outsourcing-facility-fees http://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions Human drug compounding; FDA inspections; compounding recalls Tue, 01 Aug 2023 10:24:19 EDT FDA http://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists Generic Drug Facilities, Sites and Organization Lists Tue, 01 Aug 2023 10:16:01 EDT FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists