Calendar

pharmadog

Week of Mar 24, 2025

Mar 26, 2025approval523d agoLORAZEPAM — FDA approvallorazepam ER

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →lorazepam ER →fda approvals ↗

Mar 26, 2025approval523d agoLORAZEPAM — FDA approvallorazepam ER

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →lorazepam ER →fda approvals ↗

Mar 26, 2025approval523d agoLORAZEPAM — FDA approvallorazepam ER

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →lorazepam ER →fda approvals ↗

Mar 26, 2025approval523d agoSTIMUFEND (PEGFILGRASTIM-FPGK) — FDA approvalSTIMUFEND

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

full page →STIMUFEND →fda approvals ↗

Mar 26, 2025approval523d agoRINVOQ LQ (UPADACITINIB) — FDA approvalupadacitinib

Sponsor: ABBVIE. Form: SOLUTION. Route: ORAL

full page →upadacitinib →fda approvals ↗

Mar 26, 2025approval523d agoRINVOQ (UPADACITINIB) — FDA approvalupadacitinib tartrate ER

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

full page →upadacitinib tartrate ER →fda approvals ↗

Mar 26, 2025approval523d agoCABOMETYX (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

Sponsor: EXELIXIS INC. Form: TABLET. Route: ORAL

full page →cabozantinib s-malate →fda approvals ↗

Mar 26, 2025recall523d agoFruit Of The Earth, Inc. recall (Cls II)CVS HEALTH Corp

CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc — Reason: Chemical contamination: presence of benzene — Status: Ongoing

full page →fda recalls ↗

Mar 26, 2025recall523d agoAmgen, Inc. recall (Cls II)AMGEN INC

Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-530-01 (vial), NDC 55513-530-10 (box). — Reason: Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. — Status: Ongoing

full page →fda recalls ↗

Mar 26, 2025recall523d agoMYLAN PHARMACEUTICALS INC recall (Cls II)MIRA PHARMACEUTICALS, INC.

Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93 — Reason: Failed Dissolution Specifications - low dissolution results — Status: Ongoing

full page →fda recalls ↗

Mar 26, 2025recall523d agoFDC Limited recall (Cls II)FDC Ltd

Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05 — Reason: Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle — Status: Ongoing

full page →fda recalls ↗

Mar 26, 2025recall523d agoMylan Institutional, Inc. recall (Cls II)Mylan Institutional Inc

Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-443-20. — Reason: Super-Potent Drug: Out of specification potency results were obtained. — Status: Ongoing

full page →fda recalls ↗

Mar 26, 2025recall523d agoSlate Run Pharmaceuticals recall (Cls II)Slate Run Pharmaceuticals LLC

Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04 — Reason: CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. — Status: Ongoing

full page →fda recalls ↗

Mar 26, 2025recall523d agoMEDLINE INDUSTRIES, LP - Northfield recall (Cls II)

CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30. — Reason: Subpotent Drug — Status: Ongoing

full page →fda recalls ↗

Mar 26, 2025recall523d agoMEDLINE INDUSTRIES, LP - Northfield recall (Cls II)

Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30. — Reason: Subpotent Drug — Status: Ongoing

full page →fda recalls ↗

Mar 26, 2025recall523d agoFruit Of The Earth, Inc. recall (Cls II)Galderma Laboratories LP

Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton; Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015 — Reason: Chemical contamination: presence of benzene — Status: Ongoing

full page →fda recalls ↗

Mar 26, 2025recall523d agoOne Source Nutrition, Inc, recall (Cls I)Shenzhen Hanhui Pharmaceutical Technology Co Ltd

Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency. — Reason: Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil. — Status: Ongoing

full page →fda recalls ↗

Mar 26, 2025recall523d agoAmgen, Inc. recall (Cls II)AMGEN INC

Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc. Thousand Oaks, CA 91320, NDC 55513-546-01 (vial), NDC 55513-546-10 (box). — Reason: Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. — Status: Ongoing

full page →fda recalls ↗

Mar 26, 2025recall523d agoMylan Institutional, Inc. recall (Cls II)Mylan Institutional Inc

Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20. — Reason: Super-Potent Drug: Out of specification potency results were obtained. — Status: Ongoing

full page →fda recalls ↗

Mar 26, 2025recall523d agoSlate Run Pharmaceuticals recall (Cls II)Slate Run Pharmaceuticals LLC

Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04 — Reason: CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. — Status: Ongoing

full page →fda recalls ↗

Mar 26, 2025recall523d agoGolden State Medical Supply Inc. recall (Cls II)Apotex Corp

PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30 — Reason: Failed Dissolution Specifications — Status: Ongoing

full page →fda recalls ↗

Mar 26, 2025recall523d agoRising Pharma Holding, Inc. recall (Cls II)CHINA PHARMA HOLDINGS, INC.

Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit. — Status: Ongoing

full page →fda recalls ↗

Mar 27, 2025approval522d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Mar 27, 2025approval522d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Mar 27, 2025approval522d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Mar 27, 2025approval522d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: VISTAPHARM LLC. Form: TABLET. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Mar 28, 2025approval521d agoPLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) — FDA approvallutetium Lu 177 vipivotide tetraxetan

Sponsor: NOVARTIS. Form: SOLUTION. Route: INTRAVENOUS

full page →lutetium Lu 177 vipivotide tetraxetan →fda approvals ↗

Mar 28, 2025approval521d agoPLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) — FDA approvallutetium Lu 177 vipivotide tetraxetan

Sponsor: NOVARTIS. Form: SOLUTION. Route: INTRAVENOUS

full page →lutetium Lu 177 vipivotide tetraxetan →fda approvals ↗

Mar 28, 2025approval521d agoABILIFY MAINTENA KIT (ARIPIPRAZOLE) — FDA approvalaripiprazole LA

Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →aripiprazole LA →fda approvals ↗

Mar 28, 2025approval521d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Mar 28, 2025approval521d agoBRIXADI (BUPRENORPHINE) — FDA approvalbuprenorphine LA

Sponsor: BRAEBURN. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS

full page →buprenorphine LA →fda approvals ↗

Mar 28, 2025approval521d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Mar 28, 2025approval521d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 28, 2025approval521d agoADZENYS XR-ODT (AMPHETAMINE) — FDA approvalTraws Pharma, Inc.

Sponsor: NEOS THERAPS. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Week of Mar 31, 2025

Mar 31, 2025approval518d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Mar 31, 2025approval

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