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Week of Apr 28, 2025

42

Apr 29, 2025approval469d agoDIVIGEL (ESTRADIOL) — FDA approvalVertical Pharmaceuticals LLC

Sponsor: VERTICAL PHARMS. Form: GEL. Route: TRANSDERMAL

full page →fda approvals ↗

Apr 29, 2025approval469d agoBLINCYTO (BLINATUMOMAB) — FDA approvalblinatumomab

Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION

full page →blinatumomab →fda approvals ↗

Apr 30, 2025approval468d agoZEPZELCA (LURBINECTEDIN) — FDA approvallurbinectedin

Sponsor: JAZZ. Form: POWDER. Route: INTRAVENOUS

full page →lurbinectedin →fda approvals ↗

Apr 30, 2025approval468d agoEPYSQLI (ECULIZUMAB-AAGH) — FDA approvalEPYSQLI

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION

full page →EPYSQLI →fda approvals ↗

Apr 30, 2025approval468d agoOTULFI (USTEKINUMAB-AAUZ) — FDA approvalOTULFI

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION

full page →OTULFI →fda approvals ↗

Apr 30, 2025approval468d agoOTULFI (USTEKINUMAB-AAUZ) — FDA approvalOTULFI

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION

full page →OTULFI →fda approvals ↗

Apr 30, 2025approval468d agoYESINTEK (USTEKINUMAB-KFCE) — FDA approvalustekinumab biosimilar

Sponsor: BIOCON BIOLOGICS INC. Form: INJECTABLE. Route: INJECTION

full page →ustekinumab biosimilar →fda approvals ↗

Apr 30, 2025approval468d agoPREGABALIN — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: INVAGEN PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Apr 30, 2025approval468d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

Sponsor: NOVITIUM PHARMA. Form: CAPSULE. Route: ORAL

full page →BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE →fda approvals ↗

Apr 30, 2025approval468d agoSTEQEYMA (USTEKINUMAB-STBA) — FDA approvalSTEQEYMA

Sponsor: CELLTRION, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →STEQEYMA →fda approvals ↗

Apr 30, 2025approval468d agoSELARSDI (USTEKINUMAB-AEKN) — FDA approvalAlvotech

Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Apr 30, 2025approval468d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

full page →PYZCHIVA →fda approvals ↗

Apr 30, 2025approval468d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

full page →PYZCHIVA →fda approvals ↗

Apr 30, 2025approval468d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →PYZCHIVA →fda approvals ↗

Apr 30, 2025recall468d agoApipharma recall (Cls II)

Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distributed by: Apipharma, LLC, Tempe, AZ UPC 3 858882 103534 and UPC 3 858882 101318 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Apr 30, 2025recall468d agoDenver Solutions, LLC DBA Leiters Health recall (Cls II)Fresenius Kabi USA LLC

Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11 — Reason: Lack of Assurance of Sterility: Leaking/damaged syringes. — Status: Ongoing

full page →fda recalls ↗

Apr 30, 2025recall468d agoPharmadel, LLC recall (Cls II)PharmaDerm LLC

Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-406-30 — Reason: cGMP deviations — Status: Terminated

full page →fda recalls ↗

Apr 30, 2025recall468d agoPharmadel, LLC recall (Cls II)PharmaDerm LLC

DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-400-15 — Reason: cGMP deviations — Status: Terminated

full page →fda recalls ↗

Apr 30, 2025recall468d agoBreckenridge Pharmaceutical, Inc recall (Cls II)Breckenridge Pharmaceutical Inc

Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10 — Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. — Status: Ongoing

full page →fda recalls ↗

Apr 30, 2025recall468d agoAmerisource Health Services LLC recall (Cls II)Somerset Therapeutics LLC

Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41. — Reason: Lack of assurance of sterility. Bacterial contamination detected in some media fill units — Status: Ongoing

full page →fda recalls ↗

Apr 30, 2025recall468d agoBreckenridge Pharmaceutical, Inc recall (Cls II)Breckenridge Pharmaceutical Inc

Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922 — Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. — Status: Ongoing

full page →fda recalls ↗

Apr 30, 2025recall468d agoMedisca Inc. recall (Cls II)SpyGlass Pharma, Inc.

Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Plattsburgh, NY — Reason: CGMP Deviations — Status: Terminated

full page →fda recalls ↗

Apr 30, 2025recall468d agoAmerisource Health Services LLC recall (Cls II)Somerset Therapeutics LLC

Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-581-48. — Reason: Lack of assurance of sterility. Bacterial contamination detected in some media fill units — Status: Ongoing

full page →fda recalls ↗

Apr 30, 2025recall468d agoAmerisource Health Services LLC recall (Cls II)Somerset Therapeutics LLC

Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41. — Reason: Lack of assurance of sterility. Bacterial contamination detected in some media fill units — Status: Ongoing

full page →fda recalls ↗

Apr 30, 2025recall468d agoPharmadel, LLC recall (Cls II)PharmaDerm LLC

Kingskin, Elimina Las Verrugas, For the removal of common warts, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-409-15 — Reason: cGMP deviations — Status: Terminated

full page →fda recalls ↗

Apr 30, 2025recall468d agoPharmadel, LLC recall (Cls II)PharmaDerm LLC

Rapidol Arnica Gel, Topical Gel, Homeopathic Medicine, 2 oz (57 g), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-403-02 — Reason: cGMP deviations — Status: Terminated

full page →fda recalls ↗

Apr 30, 2025recall468d agoPharmadel, LLC recall (Cls II)PharmaDerm LLC

DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15 — Reason: cGMP deviations — Status: Terminated

full page →fda recalls ↗

Apr 30, 2025recall468d agoOurPharma LLC recall (Cls III)SpecGx LLC

HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01. — Reason: Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification.. — Status: Terminated

full page →fda recalls ↗

Apr 30, 2025recall468d agoDenver Solutions, LLC DBA Leiters Health recall (Cls II)BioXcel Therapeutics, Inc.

dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11. — Reason: Lack of Assurance of Sterility: Leaking/damaged syringes. — Status: Ongoing

full page →fda recalls ↗

Apr 30, 2025recall468d agoLupin Pharmaceuticals Inc. recall (Cls II)LB PHARMACEUTICALS INC

clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01 — Reason: Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study. — Status: Terminated

full page →fda recalls ↗

Apr 30, 2025recall468d agoDenver Solutions, LLC DBA Leiters Health recall (Cls II)Fresenius Kabi USA LLC

Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11 — Reason: Lack of Assurance of Sterility: Leaking/damaged syringes. — Status: Ongoing

full page →fda recalls ↗

Apr 30, 2025recall468d agoDenver Solutions, LLC DBA Leiters Health recall (Cls II)NRX Pharmaceuticals, Inc.

Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11 — Reason: Lack of Assurance of Sterility: Leaking/damaged syringes. — Status: Ongoing

full page →fda recalls ↗

Apr 30, 2025recall468d agoApipharma recall (Cls II)Grunenthal GmbH

Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima Kavanjina 26, 10090 Zagreb, Croatia, Distributed by: Apipharma, LLC, 2331 West Alameda Drive, Tempe, AZ 85282 UPC 3 858882 101363 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Apr 30, 2025recall468d agoDenver Solutions, LLC DBA Leiters Health recall (Cls II)Revalesio Corp

PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11, — Reason: Lack of Assurance of Sterility: Leaking/damaged syringes. — Status: Ongoing

full page →fda recalls ↗

Apr 30, 2025recall468d agoPharmadel, LLC recall (Cls II)PharmaDerm LLC

Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-405-99 — Reason: cGMP deviations — Status: Terminated

full page →fda recalls ↗

Apr 30, 2025recall468d agoRemedyRepack Inc. recall (Cls II)RemedyRepack Inc

Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

May 1, 2025approval467d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

Sponsor: ABBVIE. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

May 1, 2025approval467d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

May 1, 2025approval467d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

Sponsor: ABBVIE. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

May 1, 2025approval467d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

full page →fda approvals ↗

May 1, 2025approval467d agoTICAGRELOR — FDA approvalTICAGRELOR

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →TICAGRELOR →fda approvals ↗

May 2, 2025approval466d agoTICAGRELOR — FDA approvalTICAGRELOR

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →TICAGRELOR →fda approvals ↗

Week of May 5, 2025

8

May 5, 2025approval463d agoTICAGRELOR — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: INVAGEN PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

May 5, 2025approval

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