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Updated Monday through Friday

November 30, 2021

Drugs@FDA Data Files (updated)
FDA Drug Shortages
- Amphetamine Oral Suspension, Extended Release (New - Currently in Shortage)
- Betamethasone Valerate Topical Foam (New - Discontinuation)
- Clonidine Hydrochloride Extended Release Tablets (New - Discontinuation)
- Febuxostat Tablets (New - Discontinuation)
- Sterile Water for Injection (New - Currently in Shortage)
Generic Drug Research Priorities & Projects (updated)

November 29, 2021

FDA Drug Shortages
- Dexmedetomidine Injection (Updated - Currently in Shortage)
Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry
Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present (updated)
Final Agenda for the November 30, 2021 Meeting of the Antimicrobial Drugs Advisory Committee (updated)

November 26, 2021

Competitive Generic Therapy Approvals

November 24, 2021

Drugs@FDA Data Files (updated)

November 23, 2021

FDA approves sirolimus protein-bound particles for malignant perivascular epithelioid cell tumor
FDA Drug Shortages
- Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Sterile Water for Injection (New - Currently in Shortage)
Impact Story: Improving Dose Selection In Children through Better Estimates of Renal Function

November 22, 2021

FDA Health Playbook - series of public service announcements (PSAs) within the Remove the Risk campaign
FDA Drug Shortages
- Febuxostat Tablets (New - Discontinuation)
Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Levetiracetam Injection, USP Due to Lack of Sterility Assurance

November 18, 2021

FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Bumetanide Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Cefoxitin for Injection (Updated - Resolved)
- Cefoxitin for Injection (Updated - Resolved)
- Chlordiazepoxide Hydrochloride Capsules (New - Currently in Shortage)
- Chlordiazepoxide Hydrochloride Capsules (Updated - Currently in Shortage)
- Cytarabine Injection (Updated - Currently in Shortage)
- Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
- Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
- Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
- Furosemide Injection (Updated - Currently in Shortage)
- Gentamicin Sulfate Injection (Updated - Currently in Shortage)
- Ketamine Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Mannitol Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
- Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
- Propofol Injectable Emulsion (Updated - Currently in Shortage)
- Sodium Bicarbonate Injection (Updated - Currently in Shortage)
- Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
- Vecuronium Bromide for Injection (Updated - Currently in Shortage)
Updates on possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products

November 17, 2021

美国食品药品监督管理局警告含酒精洗手液进入眼睛可能会导致严重伤害 (Chinese language version of "FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury")
Ongoing | Cancer Accelerated Approvals (updated)
FDA Drug Shortages
- Nefazodone Hydrochloride Tablets (Updated - Currently in Shortage)

November 16, 2021

Competitive Generic Therapy Approvals (updated)
Drugs@FDA Data Files (updated)
Patent Certifications and Suitability Petitions (updated)
FDA Drug Shortages
- Clobetasol Propionate Topical Foam (New - Discontinuation)
- Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection (Updated - Currently in Shortage)
SterRx, LLC Issues Voluntary Nationwide Recall of Certain SterRx Products

November 15, 2021

FDA Drug Shortages
- Methohexital Sodium (Brevital) Injection (Updated - Resolved)
Model-Informed Drug Development Pilot Program (updated)

November 12, 2021

FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
Orange Book
- Orange Book Current Cumulative Supplement (updated)
- Additions/Deletions for Prescription and OTC Drug Product Lists (updated)
- Orange Book Data Files (compressed) (updated)
- Reference Listed Drugs by ANDA Reference Standard List (updated)
- Orange Book Patent Listing Dispute List (updated)

November 10, 2021

FDA Drug Shortages
- Famotidine Injection (Updated - Resolved)
- Famotidine Tablets (Updated - Resolved)

November 9, 2021

Comunicado sobre la seguridad de los medicamentos de la FDA: La FDA advierte que el contacto del desinfectante de manos a base de alcohol con los ojos puede causar lesiones graves Enjuagar inmediatamente los ojos con abundante agua corriente si esto ocurre
Drugs@FDA Data Files (updated)
Impact Story: Exploiting Real-World Data to Optimize the Use of Antibiotics
FDA Adverse Event Reporting System (FAERS) Electronic Submissions (updated)

November 8, 2021

FDA Drug Shortages
- Amoxapine Tablets (Updated - Currently in Shortage)
- Azacitidine for Injection (Updated - Currently in Shortage)
- Famotidine Tablets (Updated - Currently in Shortage)
- Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
- Leuprolide Acetate Injection (Updated - Currently in Shortage)
- Loxapine Capsules (Updated - Currently in Shortage)
- Nizatidine Capsules (Updated - Currently in Shortage)
- Propofol Injectable Emulsion (Updated - Currently in Shortage)
Public Meeting on Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (DSCSA) (updated)

November 5, 2021

FDA Drug Shortages
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
- Ethambutol Hydrochloride Tablets (New - Discontinuation)
- Furosemide Injection (New - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Methimazole Tablets (New - Discontinuation)
- Vecuronium Bromide for Injection (Updated - Currently in Shortage)

November 4, 2021

FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Calcium Gluconate Injection (Updated - Currently in Shortage)
- Chloroprocaine Hydrochloride Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
- Furosemide Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
- Mannitol Injection (Updated - Currently in Shortage)
- Mepivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Sodium Acetate Injection (Updated - Currently in Shortage)
- Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
- Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)

November 3, 2021

November 2, 2021

Drugs@FDA Data Files (updated)
FDA Drug Safety Communication: FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury
Patent Certifications and Suitability Petitions (updated)
Memorandum of Understanding Addressing Certain Distributions of Compounded Drugs (updated)
FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Bumetanide Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Cytarabine Injection (Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Disopyramide Phosphate (Norpace) Capsules (Updated - Currently in Shortage)
- Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
- Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
- Echothiophate Iodide (Phospholine Iodide) Ophthalmic Solution (Updated - Currently in Shortage)
- Efavirenz Tablets (New - Discontinuation)
- Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
- Furosemide Injection (Updated - Currently in Shortage)
- Gentamicin Sulfate Injection (Updated - Currently in Shortage)
- Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- Hydrocortisone Tablets (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Ketamine Injection (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
- Lorazepam Injection (Updated - Currently in Shortage)
- Mannitol Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Misoprostol Tablets (Updated - Currently in Shortage)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
- Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
- Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
- Potassium Acetate Injection (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (New - Currently in Shortage)
- Propofol Injectable Emulsion (Updated - Currently in Shortage)
- Sodium Bicarbonate Injection (Updated - Currently in Shortage)
- Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
- Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
- Sulfasalazine Tablets (Updated - Currently in Shortage)

November 1, 2021

October 29, 2021

Competitive Generic Therapy Approvals
FDA Drug Shortages
- Cefdinir Powder for Suspension (New - Discontinuation)
- Lipid Injection (Updated - Currently in Shortage)
Guidance for Industry:
- Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry
- Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide