U.S. Food & Drug Administration (FDA) latest

FDA Consumer Health Information

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Is It Really 'FDA Approved?'

How can you know for sure what the U.S. Food and Drug Administration regulates? FDA is responsible for protecting the public health by regulating human drugs and biologics, animal drugs, medical devices, tobacco products, food and animal feed, cosmetics, and products that emit radiation.

Here is a guide to how FDA regulates products —and what the agency does (and doesn’t) approve.

What's New on the FDA Drugs Site

January 13, 2017

• Drug Trials Snapshots: SPINRAZA
• FDA Drug Shortages
  • Calcium Gluconate Injection (Updated - Currently in Shortage)
  • Cefepime Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Methylprednisolone Sodium Succinate for Injection, USP (Updated - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
  • Potassium Chloride Injection (Updated - Currently in Shortage)
  • Ranitidine Injection, USP (Updated - Currently in Shortage)
  • Scopolamine (Transderm Scop) Transdermal System Patch (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
• Update: FDA revises final guidances on interim policy for certain bulk drug substances used in compounding
• Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act
  Guidance for Industry (PDF - 134KB)
• Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act
  Guidance for Industry (PDF - 112KB)
• Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry (PDF - 200KB)
• Referencing Approved Drug Products in ANDA Submissions Guidance for Industry (PDF - 155KB)

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New and Generic Drug Approvals

January 12, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Fentora  NDA #021947	Fentanyl Citrate	Tablet; Buccal, Sublingual	SUPPL-26	Cephalon	MANUF (CMC)	Approved
Fluoxetine Hydrochloride  ANDA #076024	Fluoxetine Hydrochloride	Tablet; Oral	SUPPL-3	Sandoz	LABELING	Approved
Levo-T  NDA #021342	Levothyroxine Sodium	Tablet; Oral	SUPPL-25	Alara Pharm	MANUF (CMC)	Approved
Norditropin  NDA #021148	Somatropin Recombinant	Injectable; Injection	SUPPL-47	Novo Nordisk Inc	MANUF (CMC)	Approved
Norditropin Flexpro  NDA #021148	Somatropin Recombinant	Injectable; Injection	SUPPL-47	Novo Nordisk Inc	MANUF (CMC)	Approved
Norditropin Nordiflex  NDA #021148	Somatropin Recombinant	Injectable; Injection	SUPPL-47	Novo Nordisk Inc	MANUF (CMC)	Approved
Septocaine  NDA #020971	Articaine Hydrochloride; Epinephrine Bitartrate	Injectable; Injection	SUPPL-36	Deproco	MANUF (CMC)	Approved
Suboxone  NDA #022410	Buprenorphine Hydrochloride; Naloxone Hydrochloride	Film; Buccal, Sublingual	SUPPL-28	Indivior Inc	MANUF (CMC)	Approved