Calendar

pharmadog

Week of Mar 23, 2026

Mar 23, 2026approval160d agoMEXILETINE HYDROCHLORIDE — FDA approvalMEXILETINE HYDROCHLORIDE

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

full page →MEXILETINE HYDROCHLORIDE →fda approvals ↗

Mar 23, 2026approval160d agoMALARONE PEDIATRIC (ATOVAQUONE) — FDA approvalatovaquone

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →atovaquone →fda approvals ↗

Mar 24, 2026approval159d agoBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE) — FDA approvalAurobindo Pharma Ltd

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

full page →fda approvals ↗

Mar 24, 2026approval159d agoGUANFACINE HYDROCHLORIDE — FDA approvalGUANFACINE HYDROCHLORIDE

Sponsor: ASCENT PHARMS INC. Form: TABLET. Route: ORAL

full page →GUANFACINE HYDROCHLORIDE →fda approvals ↗

Mar 24, 2026approval159d agoTICAGRELOR — FDA approvalTICAGRELOR

Sponsor: ZHEJIANG JINGXIN. Form: TABLET. Route: ORAL

full page →TICAGRELOR →fda approvals ↗

Mar 24, 2026approval159d agoAVLAYAH (TIVIDENOFUSP ALFA-EKNM) — FDA approvaltividenofusp alfa

Sponsor: DENALI THERAPEUTICS INC.. Form: INJECTION. Route: POWDER,FOR SOLUTION

full page →tividenofusp alfa →fda approvals ↗

Mar 24, 2026approval159d agoCHILDREN'S ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL

full page →fda approvals ↗

Mar 24, 2026approval159d agoDYNACIN (MINOCYCLINE HYDROCHLORIDE) — FDA approvalMINOCYCLINE HYDROCHLORIDE

Sponsor: ALVOGEN. Form: CAPSULE. Route: ORAL

full page →MINOCYCLINE HYDROCHLORIDE →fda approvals ↗

Mar 24, 2026approval159d agoDYNACIN (MINOCYCLINE HYDROCHLORIDE) — FDA approvalMINOCYCLINE HYDROCHLORIDE

Sponsor: ALVOGEN. Form: CAPSULE. Route: ORAL

full page →MINOCYCLINE HYDROCHLORIDE →fda approvals ↗

Mar 24, 2026approval159d agoDYNACIN (MINOCYCLINE HYDROCHLORIDE) — FDA approvalMINOCYCLINE HYDROCHLORIDE

Sponsor: ALVOGEN. Form: CAPSULE. Route: ORAL

full page →MINOCYCLINE HYDROCHLORIDE →fda approvals ↗

Mar 24, 2026approval159d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

Mar 24, 2026approval159d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

Mar 24, 2026approval159d agoRINGER'S IN PLASTIC CONTAINER (CALCIUM CHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: OTSUKA ICU MEDCL. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 25, 2026approval158d agoMARINOL (DRONABINOL) — FDA approvalVertanical GmbH

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

full page →fda approvals ↗

Mar 25, 2026approval158d agoTRETINOIN — FDA approvalMylan Pharmaceuticals Inc

Sponsor: ENCUBE. Form: CREAM. Route: TOPICAL

full page →fda approvals ↗

Mar 25, 2026approval158d agoELREXFIO (ELRANATAMAB) — FDA approvalelranatamab

Sponsor: PFIZER INC. Form: SOLUTION. Route: INJECTION

full page →elranatamab →fda approvals ↗

Mar 25, 2026approval158d agoWINREVAIR (SOTATERCEPT-CSRK) — FDA approvalsotatercept

Sponsor: MERCK SHARP DOHME. Form: INJECTABLE. Route: INJECTION

full page →sotatercept →fda approvals ↗

Mar 25, 2026approval158d agoLIFYORLI (COPACKAGED) (RELACORILANT) — FDA approvalCORCEPT THERAPEUTICS INC

Sponsor: CORCEPT THERAP. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Mar 25, 2026approval158d agoKRAZATI (ADAGRASIB) — FDA approvalBristol-Myers Squibb Co

Sponsor: BRISTOL. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 25, 2026approval158d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalMETHYLPHENIDATE HYDROCHLORIDE

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

full page →METHYLPHENIDATE HYDROCHLORIDE →fda approvals ↗

Mar 25, 2026recall158d agoApotex Corp. recall (Cls II)Apotex Corp

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Mar 25, 2026recall158d agoSTRIDES PHARMA INC recall (Cls II)Strides Pharma Inc

Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8. — Reason: Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. — Status: Ongoing

full page →fda recalls ↗

Mar 25, 2026recall158d agoAnnora Pharma Private Limited recall (Cls III)Annora Pharma Pvt Ltd

Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India, NDC 72603-479-01. — Reason: Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg — Status: Ongoing

full page →fda recalls ↗

Mar 25, 2026recall158d agoCardinal Health 200, LLC recall (Not Yet Classified)CARDINAL HEALTH INC

Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085. — Reason: Microbial Contamination of Sterile Products: Affected lots have been deemed non-sterile following discovery of a contaminant (Paenibacillus phoenicis), which may pose a potential infection risk to vulnerable groups. — Status: Ongoing

full page →fda recalls ↗

Mar 25, 2026recall158d agoSOMERSET THERAPEUTICS LLC recall (Cls II)Somerset Therapeutics LLC

Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-025-10; NDC vial: 70069-025-01 — Reason: Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate. — Status: Ongoing

full page →fda recalls ↗

Mar 26, 2026approval157d agoCLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →CLEOCIN →fda approvals ↗

Mar 26, 2026approval157d agoBKEMV (ECULIZUMAB-AEEB) — FDA approvaleculizumab biosimilar

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

full page →eculizumab biosimilar →fda approvals ↗

Mar 26, 2026approval157d agoCLEOCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) — FDA approvalclindamycin hydrochloride

Sponsor: PFIZER. Form: CAPSULE. Route: ORAL

full page →clindamycin hydrochloride →fda approvals ↗

Mar 26, 2026approval157d agoNOREPINEPHRINE BITARTRATE IN 5% DEXTROSE (NOREPINEPHRINE BITARTRATE) — FDA approvalNOREPINEPHRINE BITARTRATE

Sponsor: SAGENT. Form: SOLUTION. Route: INTRAVENOUS

full page →NOREPINEPHRINE BITARTRATE →fda approvals ↗

Mar 26, 2026approval157d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

full page →Spexotras →fda approvals ↗

Mar 26, 2026approval157d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

Mar 26, 2026approval157d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗

Mar 26, 2026approval157d agoCLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →CLEOCIN →fda approvals ↗

Mar 26, 2026approval157d agoKADCYLA (ADO-TRASTUZUMAB EMTANSINE) — FDA approvaltrastuzumab emtansine

Sponsor: GENENTECH. Form: VIAL. Route: SINGLE-USE

full page →trastuzumab emtansine →fda approvals ↗

Mar 26, 2026approval157d agoAWIQLI FLEXTOUCH (INSULIN ICODEC) — FDA approvalinsulin icodec

Sponsor: NOVO NORDISK INC. Form: INJECTION. Route: SOLUTION

full page →insulin icodec →fda approvals ↗

Mar 26, 2026approval157d agoLABETALOL HYDROCHLORIDE — FDA approvalLABETALOL HYDROCHLORIDE

Sponsor: HERITAGE PHARMA. Form: TABLET. Route: ORAL

full page →LABETALOL HYDROCHLORIDE →fda approvals ↗

Mar 26, 2026approval157d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

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

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Mar 26, 2026approval157d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

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

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Mar 26, 2026approval157d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

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

full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗

Mar 26, 2026approval157d agoNEFFY (EPINEPHRINE) — FDA approvalInternational Medication Systems Ltd

Sponsor: ARS PHARMS OPERATION. Form: SPRAY. Route: NASAL

full page →fda approvals ↗

Mar 26, 2026approval157d agoNEFFY (EPINEPHRINE) — FDA approvalInternational Medication Systems Ltd

Sponsor: ARS PHARMS OPERATION. Form: SPRAY. Route: NASAL

full page →fda approvals ↗

Mar 26, 2026approval157d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

Mar 27, 2026approval156d agoEPKINLY (EPCORITAMAB-BYSP) — FDA approvalepcoritamab

Sponsor: GENMAB US, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →epcoritamab →fda approvals ↗

Mar 27, 2026approval156d agoALYFTREK (DEUTIVACAFTOR) — FDA approval(deutivacaftor + tezacaftor + vanzacaftor calcium)

Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

full page →(deutivacaftor + tezacaftor + vanzacaftor calcium) →fda approvals ↗

Mar 27, 2026approval156d agoALLI (ORLISTAT) — FDA approvalH2-Pharma LLC

Sponsor: HALEON US HOLDINGS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Mar 27, 2026approval156d agoPONLIMSI (DENOSUMAB-ADET) — FDA approvalPONLIMSI

Sponsor: TEVA PHARMACEUTICALS, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →PONLIMSI →fda approvals ↗

Mar 27, 2026approval156d agoZEJULA (NIRAPARIB TOSYLATE) — FDA approvalniraparib

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →niraparib →fda approvals ↗

Mar 27, 2026approval156d agoDAYBUE (TROFINETIDE) — FDA approvaltrofinetide

Sponsor: ACADIA PHARMS INC. Form: SOLUTION. Route: ORAL

full page →trofinetide →fda approvals ↗

Mar 27, 2026approval156d agoCARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER (NICARDIPINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: CHIESI. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Mar 27, 2026approval156d agoDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ATROPINE SULFATE) — FDA approvalATROPINE SULFATE

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

full page →ATROPINE SULFATE →fda approvals ↗

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Week of Mar 23, 2026