FDA Roundup: September 27, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
September 27, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia
FDA approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targ
FDA is alerting patients and health care professionals about the voluntary withdrawal of Oxbryta from the market due to safety concerns
FDA is alerting patients and health care professionals about the voluntary withdrawal of Oxbryta from the market due to safety concerns
Amazy contains hidden drug ingredients
The U.S. Food and Drug Administration is advising consumers not to purchase or use Amazy, a product promoted and sold for pain on various websites, including Amazon.com, and possibly in some retail stores.
Ácido Hialurónico contains hidden drug ingredient
The U.S. Food and Drug Administration is advising consumers not to purchase or use Ácido Hialurónico (or Acid Hyaluronic), a product promoted and sold for pain on various websites, including ebay, and possibly in some retail stores.
September 26, 2024
FDA approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targ
FDA notification regarding unapproved drugs included in kits
On September 20, 2024, FDA requested Azurity Pharmaceuticals Inc. stop distributing unapproved drugs marketed as “Unit-of-Use Prescription Compounding Kits.
Fagron Compounding Services, LLC dba Fagron Sterile Services. Wichita, KS. 483 issued 06/28/2024
Record Date 06/28/2024 Short Title (70 char) Fagron Compounding Services, LLC dba Fagron Sterile Services. Wichita, KS. 483 issued 06/28/2024 FEI Number 3012104093 Firm Name Fagron Compounding Service
ProRx LLC. Exton, PA. 483 issued 8/2/2024
Task Description Request Please post to the ORA Electronic Reading Room Record Date 8/2/2024 Short Title (70 char) ProRx LLC. Exton, PA. 483 issued 8/2/2024 FEI Number 3022250654 Firm Name ProRx LLC R
FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy
On September 25, 2024, the FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer.
Generic Drug Research Publications & Resources
The results of research studies conducted GDUFA initiatives provide new tools for FDA to evaluate generic drug equivalence.
TERUMO YAMAGUCHI CORPORATION - 3/30/2023
TERUMO YAMAGUCHI CORPORATION - 3/30/2023. Country: Japan. Record Type: 483
First Cah Co., Ltd. - 10/27/2023
First Cah Co., Ltd. - 10/27/2023. Country: Republic of Korea. Record Type: 483
FDA Approves New Drug to Treat Niemann-Pick Disease, Type C
FDA approved Aqneursa (levacetylleucine) for the treatment of neurological symptoms associated with Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing at least 15 kg
FDA Roundup: September 24, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
September 24, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA's ISTAND Pilot Program accepts a submission of first organ-on-a-chip technology designed to predict human drug-induced liver injury (DILI)
FDA accepts first letter of intent (LOI) into the ISTAND Pilot Program for an organ-on-a-chip technology, a type of micro-physiological system (MPS), to study drug-induced liver injury (DILI) for certain drug candidates.
Compounding Device Inlet Correction: Baxter Healthcare Corporation Updates Use Instructions for Exactamix Automated Compounding Device Inlets due to Risk for Particulate Matter in Device Components
Automated Compounding Device Inlets used with Exactamix Compounding Devices may contain particulate matter that poses a risk to patients.
Takeda Pharmaceutical Company Limited - 11/26/2019
Takeda Pharmaceutical Company Limited - 11/26/2019. Country: Japan. Record Type: 483
Azurity Pharmaceuticals, Inc. - 656489 - 09/20/2024
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug