Calendar

pharmadog

Week of Oct 27, 2025

Oct 28, 2025approval306d agoTICAGRELOR — FDA approvalTICAGRELOR

Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

full page →TICAGRELOR →fda approvals ↗

Oct 28, 2025approval306d agoDROSPIRENONE AND ESTRADIOL (DROSPIRENONE) — FDA approvalExeltis USA Inc

Sponsor: NOVAST LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 28, 2025approval306d agoJULUCA (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL

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Oct 28, 2025approval306d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

Sponsor: ALKEM LABS LTD. Form: TABLET. Route: ORAL

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Oct 28, 2025approval306d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

Sponsor: SUNSHINE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 28, 2025approval306d agoTICAGRELOR — FDA approvalInvaGen Pharmaceuticals Inc

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

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Oct 28, 2025approval306d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

Sponsor: DR REDDYS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 28, 2025approval306d agoDOVATO (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 28, 2025approval306d agoTICAGRELOR — FDA approvalTICAGRELOR

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →TICAGRELOR →fda approvals ↗

Oct 29, 2025approval305d agoKETALAR (KETAMINE HYDROCHLORIDE) — FDA approvalPar Pharmaceutical Inc

Sponsor: PH HEALTH. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Oct 29, 2025approval305d agoNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (HYDROCORTISONE) — FDA approvalET-800

Sponsor: AMNEAL. Form: SOLUTION/DROPS. Route: OTIC

full page →ET-800 →fda approvals ↗

Oct 29, 2025approval305d agoJUBBONTI (DENOSUMAB-BBDZ) — FDA approvalJUBBONTI

Sponsor: SANDOZ INC. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →JUBBONTI →fda approvals ↗

Oct 29, 2025approval305d agoHIBICLENS (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

Sponsor: MOLNLYCKE HLTH. Form: SOLUTION. Route: TOPICAL

full page →fda approvals ↗

Oct 29, 2025approval305d agoDENOSUMAB-DSSB — FDA approvaldenosumab biosimilar

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

full page →denosumab biosimilar →fda approvals ↗

Oct 29, 2025approval305d agoCONEXXENCE (DENOSUMAB-BNHT) — FDA approvalCONEXXENCE

Sponsor: FRESENIUS KABI USA LLC. Form: INJECTION

full page →CONEXXENCE →fda approvals ↗

Oct 29, 2025approval305d agoOSENVELT (DENOSUMAB-BMWO) — FDA approvalOSENVELT

Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INJECTION

full page →OSENVELT →fda approvals ↗

Oct 29, 2025approval305d agoOSVYRTI (denosumab-desu) — FDA approvalOSVYRTI

Sponsor: ACCORD BIOPHARMA INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →OSVYRTI →fda approvals ↗

Oct 29, 2025approval305d agoPOSACONAZOLE — FDA approvalPOSACONAZOLE

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

full page →POSACONAZOLE →fda approvals ↗

Oct 29, 2025approval305d agoPIFELTRO (DORAVIRINE) — FDA approvaldoravirine

Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL

full page →doravirine →fda approvals ↗

Oct 29, 2025approval305d agoDELSTRIGO (DORAVIRINE) — FDA approval(doravirine + lamivudine + tenofovir disoproxil fumarate)

Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL

full page →(doravirine + lamivudine + tenofovir disoproxil fumarate) →fda approvals ↗

Oct 29, 2025approval305d agoAUKELSO (DENOSUMAB-KYQQ) — FDA approvalAUKELSO

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

full page →AUKELSO →fda approvals ↗

Oct 29, 2025approval305d agoENOBY (DENOSUMAB-QBDE) — FDA approvalENOBY

Sponsor: HIKMA PHARMACEUTICALS USA INC. Form: SOLUTION. Route: INJECTION

full page →ENOBY →fda approvals ↗

Oct 29, 2025approval305d agoBILPREVDA (DENOSUMAB-NXXP) — FDA approvalBILPREVDA

Sponsor: SHANGHAI HENLIUS BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →BILPREVDA →fda approvals ↗

Oct 29, 2025approval305d agoVARENICLINE TARTRATE — FDA approvalVARENICLINE TARTRATE

Sponsor: MICRO LABS. Form: TABLET. Route: ORAL

full page →VARENICLINE TARTRATE →fda approvals ↗

Oct 29, 2025approval305d agoLIBTAYO (CEMIPLIMAB-RWLC) — FDA approvalcemiplimab

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INTRAVENOUS

full page →cemiplimab →fda approvals ↗

Oct 29, 2025approval305d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →LOSARTAN POTASSIUM →fda approvals ↗

Oct 29, 2025recall305d agoGraviti Pharmaceuticals Private Limited recall (Cls II)Graviti Pharmaceuticals Inc

Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03. — Reason: Failed Tablet/Capsule Specifications — Status: Ongoing

full page →fda recalls ↗

Oct 29, 2025recall305d agoLannett Company Inc. recall (Cls II)Lannett Co Inc

Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46 — Reason: Failed Dissolution Specifications — Status: Ongoing

full page →fda recalls ↗

Oct 29, 2025recall305d agoThe Harvard Drug Group LLC recall (Cls II)Almatica Pharma LLC

Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag). — Reason: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . — Status: Ongoing

full page →fda recalls ↗

Oct 29, 2025recall305d agoJB Chemicals and Pharmaceuticals Ltd recall (Cls III)Island Pharmaceuticals Ltd

Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-10. — Reason: Tablet/Capsules Imprinted with Wrong ID — Status: Ongoing

full page →fda recalls ↗

Oct 29, 2025recall305d agoibspot recall (Cls II)

Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Technology., Ltd., Address: he nan sheng zhou kou shi huai yang xian gong ye yuan qu, X003SR097N — Reason: Marketed Without an Approved NDA/ANDA — Status: Ongoing

full page →fda recalls ↗

Oct 29, 2025recall305d agoUSV Private Limited recall (Cls II)SOLA Pharmaceuticals Inc

Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810, NDC 70512-0520-05 — Reason: Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit. — Status: Ongoing

full page →fda recalls ↗

Oct 29, 2025recall305d agoMedline Industries, LP recall (Cls II)

Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 60093 USA, NDC 55329-811-30. — Reason: Subpotent Drug — Status: Ongoing

full page →fda recalls ↗

Oct 29, 2025recall305d agoThe Harvard Drug Group LLC recall (Cls II)Almatica Pharma LLC

Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 — Reason: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . — Status: Ongoing

full page →fda recalls ↗

Oct 29, 2025recall305d agoJB Chemicals and Pharmaceuticals Ltd recall (Cls III)Island Pharmaceuticals Ltd

Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-50 — Reason: Tablet/Capsules Imprinted with Wrong ID — Status: Ongoing

full page →fda recalls ↗

Oct 29, 2025recall305d agoChurch & Dwight Co., Inc. recall (Cls II)CHURCH & DWIGHT CO INC /DE/

ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25 — Reason: Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient. — Status: Ongoing

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Oct 29, 2025recall305d agoAspiro Pharma Limited recall (Cls II)Aspiro Pharma Ltd

Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana - 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label). — Reason: Presence of Particulate Matter: Particulate matter identified as glass — Status: Ongoing

full page →fda recalls ↗

Oct 29, 2025recall305d agoBristol-Myers Squibb Company recall (Cls II)BRISTOL MYERS SQUIBB CO

Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11 — Reason: Lack of Assurance of Sterility. — Status: Ongoing

full page →fda recalls ↗

Oct 30, 2025approval304d agoTYRUKO (NATALIZUMAB-SZTN) — FDA approvalnatalizumab biosimilar

Sponsor: SANDOZ INC. Form: INJECTABLE. Route: INJECTION

full page →natalizumab biosimilar →fda approvals ↗

Oct 30, 2025approval304d agoVIMIZIM (ELOSULFASE ALFA) — FDA approvalBIOMARIN PHARMACEUTICAL INC

Sponsor: BIOMARIN PHARM. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Oct 30, 2025approval304d agoHALDOL (HALOPERIDOL DECANOATE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

Oct 30, 2025approval304d agoAXITINIB — FDA approvalaxitinib SR

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →axitinib SR →fda approvals ↗

Oct 30, 2025approval304d agoEVEROLIMUS — FDA approvalPostsurgical Therapeutics Inc

Sponsor: NOVUGEN. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 31, 2025approval303d agoPENICILLIN V POTASSIUM — FDA approvalNorthstar Rx LLC

Sponsor: CHARTWELL RX. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗

Oct 31, 2025approval303d agoVOQUEZNA TRIPLE PAK (AMOXICILLIN) — FDA approvalamoxicillin + clarithromycin + vonoprazan

Sponsor: PHATHOM. Form: CAPSULE, TABLET, TABLET. Route: ORAL

full page →amoxicillin + clarithromycin + vonoprazan →fda approvals ↗

Oct 31, 2025approval303d agoVOQUEZNA DUAL PAK (AMOXICILLIN) — FDA approvalamoxicillin + vonoprazan fumarate

Sponsor: PHATHOM. Form: CAPSULE, TABLET. Route: ORAL

full page →amoxicillin + vonoprazan fumarate →fda approvals ↗

Oct 31, 2025approval303d agoPENICILLIN V POTASSIUM — FDA approvalNorthstar Rx LLC

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 31, 2025approval303d agoPENICILLIN V POTASSIUM — FDA approvalNorthstar Rx LLC

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Week of Nov 3, 2025

Nov 3, 2025approval300d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

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

full page →fda approvals ↗

Nov 3, 2025approval

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