Calendar

pharmadog

Week of Oct 27, 2025

Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalTICAGRELOR

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →TICAGRELOR →fda approvals ↗

Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalTICAGRELOR

Sponsor: MSN. Form: TABLET. Route: ORAL

full page →TICAGRELOR →fda approvals ↗

Oct 28, 2025approval305d agoENLON-PLUS (ATROPINE SULFATE) — FDA approvalAccord Healthcare Inc

Sponsor: PHARMOBEDIENT. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Oct 28, 2025approval305d agoTRIUMEQ (ABACAVIR SULFATE) — FDA approvalViiV Healthcare Company

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

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Oct 28, 2025approval305d agoENLON-PLUS (ATROPINE SULFATE) — FDA approvalAccord Healthcare Inc

Sponsor: PHARMOBEDIENT. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Oct 28, 2025approval305d agoEBGLYSS (LEBRIKIZUMAB-LBKZ) — FDA approvallebrikizumab

Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION

full page →lebrikizumab →fda approvals ↗

Oct 28, 2025approval305d agoTIVICAY (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

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Oct 28, 2025approval305d agoDEXTROAMPHETAMINE SULFATE — FDA approvalDEXTROAMPHETAMINE SULFATE

Sponsor: AZURITY. Form: TABLET. Route: ORAL

full page →DEXTROAMPHETAMINE SULFATE →fda approvals ↗

Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

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

full page →fda approvals ↗

Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalSciegen Pharmaceuticals Inc

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

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Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

Sponsor: TARO. Form: TABLET. Route: ORAL

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Oct 28, 2025approval305d agoNICARDIPINE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: QILU PHARM HAINAN. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Oct 28, 2025approval305d agoRENFLEXIS (INFLIXIMAB-ABDA) — FDA approvalinfliximab biosimilar

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

full page →infliximab biosimilar →fda approvals ↗

Oct 28, 2025approval305d agoTIVICAY PD (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

Oct 28, 2025approval305d agoTRIUMEQ PD (ABACAVIR SULFATE) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalTICAGRELOR

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

full page →TICAGRELOR →fda approvals ↗

Oct 28, 2025approval305d agoDROSPIRENONE AND ESTRADIOL (DROSPIRENONE) — FDA approvalExeltis USA Inc

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

full page →fda approvals ↗

Oct 28, 2025approval305d agoJULUCA (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

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Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

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

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Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

Sponsor: SUNSHINE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalInvaGen Pharmaceuticals Inc

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

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Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

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

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Oct 28, 2025approval305d agoDOVATO (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

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Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalTICAGRELOR

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →TICAGRELOR →fda approvals ↗

Oct 29, 2025approval304d agoKETALAR (KETAMINE HYDROCHLORIDE) — FDA approvalPar Pharmaceutical Inc

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

full page →fda approvals ↗

Oct 29, 2025approval304d 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, 2025approval304d agoJUBBONTI (DENOSUMAB-BBDZ) — FDA approvalJUBBONTI

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

full page →JUBBONTI →fda approvals ↗

Oct 29, 2025approval304d agoHIBICLENS (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

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

full page →fda approvals ↗

Oct 29, 2025approval304d agoDENOSUMAB-DSSB — FDA approvaldenosumab biosimilar

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

full page →denosumab biosimilar →fda approvals ↗

Oct 29, 2025approval304d agoCONEXXENCE (DENOSUMAB-BNHT) — FDA approvalCONEXXENCE

Sponsor: FRESENIUS KABI USA LLC. Form: INJECTION

full page →CONEXXENCE →fda approvals ↗

Oct 29, 2025approval304d agoOSENVELT (DENOSUMAB-BMWO) — FDA approvalOSENVELT

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

full page →OSENVELT →fda approvals ↗

Oct 29, 2025approval304d agoOSVYRTI (denosumab-desu) — FDA approvalOSVYRTI

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

full page →OSVYRTI →fda approvals ↗

Oct 29, 2025approval304d agoPOSACONAZOLE — FDA approvalPOSACONAZOLE

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

full page →POSACONAZOLE →fda approvals ↗

Oct 29, 2025approval304d agoPIFELTRO (DORAVIRINE) — FDA approvaldoravirine

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

full page →doravirine →fda approvals ↗

Oct 29, 2025approval304d 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, 2025approval304d agoAUKELSO (DENOSUMAB-KYQQ) — FDA approvalAUKELSO

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

full page →AUKELSO →fda approvals ↗

Oct 29, 2025approval304d agoENOBY (DENOSUMAB-QBDE) — FDA approvalENOBY

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

full page →ENOBY →fda approvals ↗

Oct 29, 2025approval304d agoBILPREVDA (DENOSUMAB-NXXP) — FDA approvalBILPREVDA

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

full page →BILPREVDA →fda approvals ↗

Oct 29, 2025approval304d agoVARENICLINE TARTRATE — FDA approvalVARENICLINE TARTRATE

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

full page →VARENICLINE TARTRATE →fda approvals ↗

Oct 29, 2025approval304d agoLIBTAYO (CEMIPLIMAB-RWLC) — FDA approvalcemiplimab

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

full page →cemiplimab →fda approvals ↗

Oct 29, 2025approval304d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →LOSARTAN POTASSIUM →fda approvals ↗

Oct 29, 2025recall304d 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, 2025recall304d 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, 2025recall304d 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, 2025recall304d 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, 2025recall304d 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, 2025recall304d 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, 2025recall304d 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, 2025recall304d 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, 2025recall304d 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 ↗

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Week of Oct 27, 2025