Calendar

pharmadog

Week of Mar 31, 2025

Apr 1, 2025approval498d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

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Apr 1, 2025approval498d agoSTELARA (USTEKINUMAB) — FDA approvalustekinumab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

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Apr 1, 2025approval498d agoADZENYS XR-ODT (AMPHETAMINE) — FDA approvalTraws Pharma, Inc.

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

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Apr 2, 2025approval497d agoVANRAFIA (ATRASENTAN HYDROCHLORIDE) — FDA approvalatrasentan hydrochloride

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →atrasentan hydrochloride →fda approvals ↗

Apr 2, 2025approval497d agoLIRAGLUTIDE — FDA approvalNovo Nordisk Inc

Sponsor: NANJING KING FRIEND. Form: SOLUTION. Route: SUBCUTANEOUS

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Apr 2, 2025approval497d agoLIDOCAINE HYDROCHLORIDE — FDA approvalInternational Medication Systems Ltd

Sponsor: ANTHEA PHARMA. Form: INJECTABLE. Route: INJECTION

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Apr 2, 2025recall497d agoA-S Medication Solutions LLC recall (Cls II)A-S Medication Solutions LLC

METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3. — Reason: Presence of Foreign Tablets/Capsules. — Status: Ongoing

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Apr 2, 2025recall497d agoQuVa Pharma, Inc. recall (Cls II)IGC Pharma, Inc.

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75 — Reason: Lack of Assurance of Sterility — Status: Ongoing

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Apr 2, 2025recall497d agoConsumer Product Partners, LLC recall (Cls II)Kortuc Japan LLC

[CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT) 946 mL per bottle, NDC 0869-0871-45; [INCORRECT BACK LABEL] Isopropyl alcohol 91%, Dist. by: Amazon.com Services, LLC, Seattle, WA 98109. — Reason: Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol — Status: Ongoing

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Apr 2, 2025recall497d agoExela Pharma Sciences LLC recall (Cls II)Exela Pharma Sciences LLC

8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4 — Reason: Lack of Assurance of Sterility — Status: Ongoing

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Apr 2, 2025recall497d agoAscent Consumer Products Inc. recall (Cls I)Reynolds Consumer Products Inc.

SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00104 1 — Reason: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus — Status: Ongoing

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Apr 2, 2025recall497d agoAscent Consumer Products Inc. recall (Cls I)Reynolds Consumer Products Inc.

SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00102 7 — Reason: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus — Status: Ongoing

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Apr 2, 2025recall497d agoQuVa Pharma, Inc. recall (Cls II)IGC Pharma, Inc.

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75 — Reason: Lack of Assurance of Sterility — Status: Ongoing

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Apr 2, 2025recall497d agoAscent Consumer Products Inc. recall (Cls I)Reynolds Consumer Products Inc.

SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00103 4 — Reason: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus — Status: Ongoing

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Apr 2, 2025recall497d agoStrides Pharma, Inc. recall (Cls II)Strides Pharma Inc

Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02 — Reason: Presence of foreign substance: Presence of Benzene. — Status: Ongoing

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Apr 2, 2025recall497d agoJohnson, S C and Son, Inc recall (Cls II)

babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada. — Reason: Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed. — Status: Ongoing

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Apr 2, 2025recall497d agoQuVa Pharma, Inc. recall (Cls II)IGC Pharma, Inc.

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1259-75 — Reason: Lack of Assurance of Sterility — Status: Ongoing

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Apr 2, 2025recall497d agoStrides Pharma, Inc. recall (Cls II)Strides Pharma Inc

Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02 — Reason: Presence of foreign substance: Presence of Benzene. — Status: Ongoing

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Apr 3, 2025approval496d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Apr 3, 2025approval496d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: WES PHARMA INC. Form: TABLET. Route: ORAL

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Apr 3, 2025approval496d agoUPLIZNA (INEBILIZUMAB-CDON) — FDA approvalHorizon Therapeutics USA Inc

Sponsor: VIELA BIO. Form: INJECTABLE. Route: INJECTION

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Apr 4, 2025approval495d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: TABLET. Route: ORAL

full page →tedizolid phosphate →fda approvals ↗

Apr 4, 2025approval495d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: POWDER. Route: INTRAVENOUS

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Apr 4, 2025approval495d agoAMBRISENTAN — FDA approvalAMBRISENTAN

Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL

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Apr 4, 2025approval495d agoAMBRISENTAN — FDA approvalAMBRISENTAN

Sponsor: SIGMAPHARM LABS LLC. Form: TABLET. Route: ORAL

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Apr 4, 2025approval495d agoAMBRISENTAN — FDA approvalSigmapharm Laboratories LLC

Sponsor: SUN PHARM. Form: TABLET. Route: ORAL

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Apr 4, 2025approval495d agoAMBRISENTAN — FDA approvalAMBRISENTAN

Sponsor: APOTEX. Form: TABLET. Route: ORAL

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Week of Apr 7, 2025

Apr 7, 2025approval492d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

full page →Spexotras →fda approvals ↗

Apr 7, 2025approval

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