Setter: A FOIA Getter

Unredacted copy of all Other Reviews posted on Drugs@FDA at the weblink https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761384Orig1s000OtherR.pdf.

Requester: Marilynn Whitney - Covington & Burling LLP

Unredacted copy of all Proprietary Name Reviews posted on Drugs@FDA at the weblink https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761384Orig1s000NameR.pdf.

Requester: Marilynn Whitney - Covington & Burling LLP

Unredacted copy of all Administrative and Correspondence Documents posted on Drugs@FDA at the weblink https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761384Orig1s000AdminCorres.pdf.

Requester: Marilynn Whitney - Covington & Burling LLP

Good Day! Based on the inspection listing we requested and received from the FDA, kindly please provide the following inspection-related documents in electronic PDF Format: The 483 (in electronic format) for the Biologics inspection of GlaxoSmithKline Biologicals SA, located at Rue De L'Institut 89, Rixensart, B-1330,…

Requester: Joshua Boloy - Redica Systems

On Feb 25, 2026 USFDA tentatively approved an ANDA217441 (ALECTINIB 150mg Capsule) to NATCO PHARMA LTD. However, the tentative approval letter is not published yet on website at Drugs@FDA. We request you to kindly publish the tentative approval letter for ANDA217441

Requester: Kalyani Vyas - Dr.Reddys Laboratories

FF Requests: FDA-FOIA-2026-466, FDA-FOIA-2025-13412, FDA-FOIA-2025-14154, and FDA-FOIA-2025-14155.

Requester: Hogan Lovells - Hogan Lovells US LLP

Please provide the FDA-483 documents pertaining to Human DRUG Inspection, for the following firm: CoreRX Inc. DBA Bend Bioscience, 14205 Myerlake Circle, Clearwater, FL, United States, (FEI: 3007209985), inspection ending 2/26/2026. Please send the attachment in pdf format.

Requester: John Schleck - GMP Trends

Please provide the FDA-483 documents pertaining to Human DRUG Inspection, for the following firm: Aphena Pharma Solutions - Maryland, LLC, 7978 Industrial Park Rd, Easton, MD, United States, (FEI: 1130591), inspection ending 2/20/2026. Please send the attachment in pdf format.

Requester: John Schleck - GMP Trends

FF Request 2025-14151

Requester: Joanna McCall - COGENCY GLOBAL INC.

Please provide the FDA-483 documents pertaining to Human DRUG Inspection, for the following firm: Curia New York Inc, 33 Riverside Ave, Rensselaer, NY, United States, (FEI: 1310298), inspection ending 2/5/2026.

Requester: John Schleck - GMP Trends

FF Request 2026-473

Requester: Joanna McCall - COGENCY GLOBAL INC.

August 21, 2024 Memorandum to the file: Risk management approach for exposures to Silver ion (Ag+; CAS Reg. No. 14701-21-4) from food contact uses.

Requester: Theresa Dankovich - Folia Materials Inc

FF Request 2025-12699

Requester: Joanna McCall - COGENCY GLOBAL INC.

FF Request 2025-12315

Requester: Hogan Lovells - Hogan Lovells US LLP

I request records sufficient to identify the Biologics License Application (BLA) number assigned to nomlabofusp (CTI-1601), submitted by Larimar Therapeutics, Inc., for the treatment of Friedreich’s ataxia (FA). If a BLA number has been assigned, please provide the BLA number

Requester: David Bender - DPB Capital

Pursuant to the Freedom of Information Act, 5 U.S.C. § 552,please provide the NDA number

Requester: David Bender - DPB Capital

I request records sufficient to identify the New Drug Application (NDA) number assigned to deucrictibant, submitted by Pharvaris N.V., for the on-demand treatment of Hereditary Angioedema (HAE) attacks. If an NDA number has been assigned, please provide the NDA number

Requester: David Bender - DPB Capital

I request records sufficient to identify the New Drug Application (NDA) number assigned to brepocitinib, submitted by Priovant Therapeutics, Inc. (a Roivant subsidiary). The application has been publicly described as having been accepted by FDA and granted Priority Review. Please provide the NDA number

Requester: David Bender - DPB Capital

I request records sufficient to identify the New Drug Application (NDA) number assigned to encaleret for the treatment of Autosomal Dominant Hypocalcemia Type 1 (ADH1). This request relates to the NDA for encaleret that has been publicly described as expected to be submitted to the FDA in the first half of 2026. If an…

Requester: David Bender - DPB Capital

Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, I request records sufficient to identify the Biologics License Application (BLA) number assigned to ST-920 (isaralgagene civaparvovec), submitted by Sangamo Therapeutics, Inc., for the treatment of Fabry disease. If a BLA number has been assigned, please prov…

Requester: David Bender - DPB Capital

I would like to receive the FDA 483 form what was issued for Inspection what was conducted on 09SEP 13SEP2019. The form was issued on 13SEP2019. It was about late reporting of SAE. The Inspection ID: 1101820 FEI: 3015480431

Requester: Viktor Vass, MD. - Viktor Vass

I request records sufficient to identify the Biologics License Application (BLA) number assigned to imsidolimab, submitted by Vanda Pharmaceuticals Inc., for the treatment of Generalized Pustular Psoriasis (GPP). If a BLA number has been assigned, please provide the BLA number

Requester: David Bender - DPB Capital

I request records sufficient to identify the New Drug Application (NDA) number assigned to gedatolisib, submitted by Celcuity Inc., for the treatment of HR-positive / HER2-negative, PIK3CA wild-type advanced breast cancer. If an NDA number has been assigned, please provide the NDA number

Requester: David Bender - DPB Capital

I request records sufficient to identify the Biologics License Application (BLA) number assigned to ivonescimab (SMT112), submitted by Summit Therapeutics Inc., for use in combination with chemotherapy for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). If a BLA number has been assigned, please provi…

Requester: David Bender - DPB Capital

I request records sufficient to identify the New Drug Application (NDA) number assigned to bezuclastinib, submitted by Cogent Biosciences, Inc., including any NDA referencing bezuclastinib in combination with sunitinib for the treatment of gastrointestinal stromal tumors (GIST). If an NDA number has been assigned, ple…

Requester: David Bender - DPB Capital

I request records sufficient to identify the Biologics License Application (BLA) number assigned to miv-cel (KYV-101) for the treatment of Stiff Person Syndrome (SPS). If a BLA number has been assigned, please provide the BLA number

Requester: David Bender - DPB Capital

I request records sufficient to identify the Biologics License Application (BLA) number assigned to veligrotug (VRDN-001), submitted by Viridian Therapeutics, Inc., for the treatment of Thyroid Eye Disease (TED). If a BLA number has been assigned, please provide the BLA number

Requester: David Bender - DPB Capital

I request records sufficient to identify the Biologics License Application (BLA) number assigned to atacicept, submitted by Vera Therapeutics, Inc., for the treatment of IgA Nephropathy (IgAN). If a BLA number has been assigned, please provide the BLA number

Requester: David Bender - DPB Capital

I request records sufficient to identify the Biologics License Application (BLA) number assigned to obexelimab, submitted by Zenas BioPharma, Inc., for the treatment of IgG4-Related Disease (IgG4-RD). If a BLA number has been assigned, please provide the BLA number

Requester: David Bender - DPB Capital

I request records sufficient to identify the New Drug Application (NDA) number assigned to lorundrostat, submitted by Mineralys Therapeutics, Inc., for the treatment of hypertension. If an NDA number has been assigned, please provide the NDA number

Requester: David Bender - DPB Capital

I request records sufficient to identify the New Drug Application (NDA) number assigned to BBP-418 for the treatment of LGMDR9 (also known as LGMD2I). If an NDA number has been assigned, please provide the NDA number

Requester: David Bender - DPB Capital

I request records sufficient to identify the New Drug Application (NDA) number assigned to zidesamtinib (NVL-520), submitted by Nuvalent, Inc. If an NDA number has been assigned, please provide the NDA number

Requester: David Bender - DPB Capital

I request records sufficient to identify the Biologics License Application (BLA) number assigned to RelabotulinumtoxinA (Relfydess™), submitted by Galderma, including Galderma or the applicable Galderma affiliate/applicant. If a BLA number has been assigned, please provide the BLA number

Requester: David Bender - DPB Capital

I request records sufficient to identify the New Drug Application (NDA) number assigned to rusfertide, submitted by Protagonist Therapeutics, Inc. and/or Takeda, for the treatment of polycythemia vera (PV). If an NDA number has been assigned, please provide the NDA number

Requester: David Bender - DPB Capital

I request records sufficient to identify the New Drug Application (NDA) number assigned to relutrigine for the treatment of SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs). If an NDA number has been assigned, please provide the NDA number

Requester: David Bender - DPB Capital

I kindly request the following in relation to ANDA 220314 (Semaglutide Injection): 1) Tentative Approval Letter 2) Approval Routing Summary Form 3) Full labeling (i.e. Prescribing Information, Medication Guide and Instructions for Use) With kind regards, Marc

Requester: Marc Scheren - Synthon B.V.

I request records sufficient to identify the Biologics License Application (BLA) number assigned to MOLBREEVI (inhaled molgramostim), submitted by Savara Inc., for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). If a BLA number has been assigned, please provide the BLA number

Requester: David Bender - DPB Capital

I am requesting to receive the summary case reports for the following case ID from the AEMS system: 26614583 Drug Name: Vyjuvek Date Range: March 2026- date the request is processed Please provide the documents electronically by email if possible.

Requester: Kristen Sellers - FOIA Professional Services

FF 2026-2069

Requester: Jodi Ware - Jodi Ware

Please provide the NDA number assigned to GTx-104 (nimodipine) for aneurysmal subarachnoid hemorrhage, sponsored by Grace Therapeutics. If an NDA has not been assigned, please provide records sufficient to identify the regulatory application type and any assigned FDA application number.

Requester: David Bender - DPB Capital

Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, I request records sufficient to identify the Biologics License Application (BLA) number assigned to veligrotug (VRDN-001), submitted by Viridian Therapeutics, Inc., for the treatment of thyroid eye disease (TED). If a BLA number has been assigned, please prov…

Requester: David Bender - DPB Capital

Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, I request records sufficient to identify the New Drug Application (NDA) number assigned to cytisinicline, submitted by Achieve Life Sciences, for the indication of smoking cessation.

Requester: David Bender - DPB Capital

Pursuant to the Freedom of Information Act, 5 U.S.C. § 552, I request records sufficient to identify the supplemental New Drug Application (sNDA) number assigned to AXS-05 (dextromethorphan HBr and bupropion HCl), submitted by Axsome Therapeutics, Inc., for the treatment of Alzheimer’s disease agitation, for which a P…

Requester: David Bender - DPB Capital

Could I please receive a copy of the inspection report from Endo's Rochester, MI facility from October 20, 2025. The inspection ID is 1287690.Thank you,Graham

Requester: Graham Vonder Haar - KVH Consulting LLC

FF Request 2026-2008

Requester: Jamerra Cherry - Hyman Phelps & McNamara, P.C.

Please provide the MedWatch reports for these 12 (sotatercept-csrk) WINREVAIR™ cases: 25803782, 25860710, 25940251, 23606250, 25131675, 25083531

Requester: Monica Martinez - Merck & Co., Inc.

FF Request 2025-7643

Requester: Jamerra Cherry - Hyman Phelps & McNamara, P.C.

Pursuant to the Freedom of Information Act, I request a list of all FDA-registered food facilities located in the state of Florida under section 415 of the Federal Food, Drug, and Cosmetic Act. Please include, where available, the following data fields for each facility: Facility name Physical address (city, state, ZI…

Requester: John Dingman - ingredients PLUS

Good Day! Based on the inspection listing we requested and received from the FDA, kindly please provide the following inspection-related documents in electronic PDF Format: The 483 (in electronic format) for the Human Drugs inspection of Aphena Pharma Solutions - Maryland, LLC, located at 7978 Industrial Park Road, Ea…

Requester: Joshua Boloy - Redica Systems

Good Day! Based on the inspection listing we requested and received from the FDA, kindly please provide the following inspection-related documents in electronic PDF Format: The 483 (in electronic format) for the Human Drugs inspection of Fresenius Kabi USA, LLC, located at 5200 Corporate Pkwy West, Wilson, North Carol…

Requester: Joshua Boloy - Redica Systems