FDA Consumer Health Information
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.
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Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry (PDF - 200KB)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)
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 |
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