Ιαν 6 τις 10:18 μ.μ.
Center for Food Safety and Applied Nutrition
Constituent Update
FDA To Provide Additional Time to Comment on Request For Information and Draft Guidance on Fiber on the Nutrition Facts Label
January 6, 2017
FDA is providing additional time to comment on the fiber documents related to the Nutrition Facts Label. FDA will provide an additional 30 days to comment on its request for scientific data, information and comments to help the agency determine whether certain fibers should be added to the definition of “dietary fiber” published as part of the Nutrition Facts label final rule. The original comment period was set to close on January 9, 2017.
FDA also plans to provide additional time to comment on its draft guidance entitled "Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30)." The comment period, originally set to close January 23, 2017, will be extended so that it ends at the same time as the comment period for the notice referenced above.
FDA will provide the exact dates for the closing of the comment periods when they are published in the Federal Register.
Original Constituent Update
November 22, 2016
FDA is publishing a request for scientific data, information and comments to help it determine whether certain fibers should be added to the definition of “dietary fiber” published as part of the Nutrition Facts label final rule. FDA’s final rule, published on May 27, 2016, required that only certain naturally occurring dietary fibers such as those found in fruits, vegetables and whole grains, and added isolated or synthetic fibers that FDA has determined have a physiological effect that is beneficial to human health, could be declared on the label under “Dietary Fiber.” Previously, fibers in foods could be labeled as dietary fiber without necessarily providing physiological effects that are beneficial to human health. Naturally occurring fibers contained in foods have already been determined to have physiological benefits. In addition to fiber that is naturally occurring in foods, the rule identified 7 fibers that, when added to foods, could be declared as “dietary fiber.”
The request for information, along with an accompanying draft guidance, will help industry understand how FDA reviews the scientific evidence to determine whether other fibers beyond the seven identified in the rule should be added to the regulations. It also provides an opportunity to add to or comment on FDA’s review of the science with respect to whether any of 26 additional specific types of fiber provide a physiological effect that is beneficial to human health and thus should be included in the fiber definition.
The comment period for the Request for Information opens on November 23, 2016 and will be open for 45 days.
01/06/2017 10:57 AM EST
Bakers of Paris is recalling plain, almond, and chocolate croissants sold in 18 Northern California Whole Foods Market stores due to an undeclared allergen. The croissants, sold individually in self-service cases and in clear plastic packs of four, are made with an egg wash which is not declared on the ingredient list. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening reactions if they consume this product. No allergic reactions have been reported to date.
For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.
What's New on the FDA Drugs Site
January 5, 2017
- FDA Drug Shortages
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (New - Discontinuation)
- Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
- La FDA revisa la descripción de los efectos secundarios para la salud mental de los medicamentos para dejar de fumar Chantix (vareniclina) y Zyban (bupropión) para reflejar las conclusiones de estudio clínico
- Pediatric Exclusivity Granted (updated)
New and Generic Drug Approvals
January 4, 2017
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Adderall 10 NDA #011522 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-43 | Teva Womens | LABELING | Approved |
| Adderall 12.5 NDA #011522 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-43 | Teva Womens | LABELING | Approved |
| Adderall 15 NDA #011522 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-43 | Teva Womens | LABELING | Approved |
| Adderall 20 NDA #011522 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-43 | Teva Womens | LABELING | Approved |
| Adderall 30 NDA #011522 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-43 | Teva Womens | LABELING | Approved |
| Adderall 5 NDA #011522 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-43 | Teva Womens | LABELING | Approved |
| Adderall 7.5 NDA #011522 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-43 | Teva Womens | LABELING | Approved |
| Adzenys Xr-Odt NDA #204326 | Amphetamine | Tablet, Orally Disintegrating, Extended Release; Oral | SUPPL-2 | Neos Theraps | LABELING | Approved |
| Amlodipine Besylate ANDA #203245 | Amlodipine Besylate | Tablet; Oral | SUPPL-4 | Unichem Labs Ltd | MANUF (CMC) | Approved |
| Amphetamine Sulfate ANDA #083901 | Amphetamine Sulfate | Tablet; Oral | SUPPL-4 | Lannett | LABELING | Approved |
| Aptensio Xr NDA #205831 | Methylphenidate Hydrochloride | Capsule, Extended Release; Oral | SUPPL-3 | Rhodes Pharms | LABELING | Approved |
| Azelastine Hydrochloride ANDA #091444 | Azelastine Hydrochloride | Spray, Metered; Nasal | SUPPL-1 | West-Ward Pharms Int | LABELING | Approved |
| Brisdelle NDA #204516 | Paroxetine Mesylate | Capsule; Oral | SUPPL-4 | Sebela Ireland Ltd | LABELING | Approved |
| Celexa NDA #020822 | Citalopram Hydrobromide | Tablet; Oral | SUPPL-47 | Forest Labs | LABELING | Approved |
| Cimzia BLA #125160 | Certolizumab Pegol | Injectable; Injection | SUPPL-270 | Ucb Inc | LABELING | Approved |
| Citalopram Hydrobromide ANDA #077043 | Citalopram Hydrobromide | Solution; Oral | SUPPL-13 | West-Ward Pharms Int | LABELING | Approved |
| Citalopram Hydrobromide ANDA #077601 | Citalopram Hydrobromide | Solution; Oral | SUPPL-6 | Apotex Inc | LABELING | Approved |
| Citalopram Hydrobromide ANDA #077629 | Citalopram Hydrobromide | Solution; Oral | SUPPL-13 | Silarx | LABELING | Approved |
| Citalopram Hydrobromide ANDA #077812 | Citalopram Hydrobromide | Solution; Oral | SUPPL-12 | Aurobindo Pharma Ltd | LABELING | Approved |
| Concerta NDA #021121 | Methylphenidate Hydrochloride | Tablet, Extended Release; Oral | SUPPL-38 | Janssen Pharms | LABELING | Approved |
| Cymbalta NDA #021427 | Duloxetine Hydrochloride | Capsule, Delayed Rel Pellets; Oral | SUPPL-49 | Lilly | LABELING | Approved |
| Daytrana NDA #021514 | Methylphenidate | Film, Extended Release; Transdermal | SUPPL-25 | Noven Pharms Inc | LABELING | Approved |
| Desoxyn NDA #005378 | Methamphetamine Hydrochloride | Tablet, Extended Release; Oral | SUPPL-31 | Recordati Rare | LABELING | Approved |
| Desoxyn NDA #005378 | Methamphetamine Hydrochloride | Tablet; Oral | SUPPL-31 | Recordati Rare | LABELING | Approved |
| Desvenlafaxine NDA #204150 | Desvenlafaxine | Tablet, Extended Release; Oral | SUPPL-5 | Alembic Pharms Ltd | LABELING | Approved |
| Desvenlafaxine NDA #205583 | Desvenlafaxine Fumarate | Tablet, Extended Release; Oral | SUPPL-5 | Sun Pharma Global | LABELING | Approved |
| Dexedrine NDA #017078 | Dextroamphetamine Sulfate | Capsule, Extended Release; Oral | SUPPL-49 | Amedra Pharms | LABELING | Approved |
| Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate ANDA #040422 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-44 | Barr | LABELING | Approved |
| Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate ANDA #040439 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-20 | Sandoz | LABELING | Approved |
| Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate ANDA #040440 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-19 | Mallinckrodt Inc | LABELING | Approved |
| Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate ANDA #040444 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-22 | Corepharma | LABELING | Approved |
| Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate ANDA #040456 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-8 | Actavis Elizabeth | LABELING | Approved |
| Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate ANDA #040480 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-22 | Sun Pharm Inds | LABELING | Approved |
| Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate ANDA #202424 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-3 | Aurolife Pharma Llc | LABELING | Approved |
| Dextroamphetamine Sulfate ANDA #040299 | Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-3 | Vintage Pharms Llc | LABELING | Approved |
| Dextroamphetamine Sulfate ANDA #040361 | Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-24 | Barr | LABELING | Approved |
| Dextroamphetamine Sulfate ANDA #040436 | Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-16 | Mallinckrodt | LABELING | Approved |
| Dextroamphetamine Sulfate ANDA #040776 | Dextroamphetamine Sulfate | Solution; Oral | SUPPL-4 | Outlook Pharms | LABELING | Approved |
| Dextroamphetamine Sulfate ANDA #083903 | Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-27 | Lannett | LABELING | Approved |
| Dextroamphetamine Sulfate ANDA #085652 | Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-4 | Lannett | LABELING | Approved |
| Dextroamphetamine Sulfate ANDA #090533 | Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-7 | Mikart | LABELING | Approved |
| Dextroamphetamine Sulfate ANDA #090652 | Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-6 | Corepharma | LABELING | Approved |
| Dextroamphetamine Sulfate ANDA #202893 | Dextroamphetamine Sulfate | Tablet; Oral | SUPPL-2 | Aurolife Pharma Llc | LABELING | Approved |
| Dextroamphetamine Sulfate ANDA #203644 | Dextroamphetamine Sulfate | Solution; Oral | SUPPL-4 | Tris Pharma Inc | LABELING | Approved |
| Dyanavel Xr NDA #208147 | Amphetamine | Suspension, Extended Release; Oral | SUPPL-2 | Tris Pharma Inc | LABELING | Approved |
| Effexor Xr NDA #020699 | Venlafaxine Hydrochloride | Capsule, Extended Release; Oral | SUPPL-107 | Wyeth Pharms Inc | LABELING | Approved |
| Evekeo ANDA #200166 | Amphetamine Sulfate | Tablet; Oral | SUPPL-5 | Arbor Pharms Llc | LABELING | Approved |
| Fetzima NDA #204168 | Levomilnacipran Hydrochloride | Capsule, Extended Release; Oral | SUPPL-4 | Forest Labs Inc | LABELING | Approved |
| Fluoxetine Hydrochloride ANDA #075292 | Fluoxetine Hydrochloride | Solution; Oral | SUPPL-19 | Apotex Inc | LABELING | Approved |
| Fluoxetine Hydrochloride ANDA #075506 | Fluoxetine Hydrochloride | Solution; Oral | SUPPL-23 | Teva | LABELING | Approved |
| Fluoxetine Hydrochloride ANDA #075514 | Fluoxetine Hydrochloride | Solution; Oral | SUPPL-14 | Wockhardt | LABELING | Approved |
| Fluoxetine Hydrochloride ANDA #075525 | Fluoxetine Hydrochloride | Solution; Oral | SUPPL-3 | Hi Tech Pharma | LABELING | Approved |
| Fluoxetine Hydrochloride ANDA #075755 | Fluoxetine Hydrochloride | Tablet; Oral | SUPPL-23 | Mylan | LABELING | Approved |
| Fluoxetine Hydrochloride ANDA #075872 | Fluoxetine Hydrochloride | Tablet; Oral | SUPPL-21 | Teva | LABELING | Approved |
| Fluoxetine Hydrochloride ANDA #075920 | Fluoxetine Hydrochloride | Solution; Oral | SUPPL-16 | Mallinckrodt | LABELING | Approved |
| Fluoxetine Hydrochloride ANDA #076006 | Fluoxetine Hydrochloride | Tablet; Oral | SUPPL-6 | Dr Reddys Labs Inc | LABELING | Approved |
| Fluoxetine Hydrochloride ANDA #076015 | Fluoxetine Hydrochloride | Solution; Oral | SUPPL-13 | Pharm Assoc | LABELING | Approved |
| Fluoxetine Hydrochloride ANDA #076022 | Fluoxetine Hydrochloride | Capsule; Oral | SUPPL-4 | Carlsbad | LABELING | Approved |
| Fluoxetine Hydrochloride ANDA #076287 | Fluoxetine Hydrochloride | Capsule; Oral | SUPPL-8 | Ani Pharms Inc | LABELING | Approved |
| Fluoxetine Hydrochloride ANDA #076458 | Fluoxetine Hydrochloride | Solution; Oral | SUPPL-8 | Lannett | LABELING | Approved |
| Fluoxetine Hydrochloride ANDA #077469 | Fluoxetine Hydrochloride | Capsule; Oral | SUPPL-13 | Sandoz | LABELING | Approved |
| Fluoxetine Hydrochloride ANDA #077849 | Fluoxetine Hydrochloride | Solution; Oral | SUPPL-10 | Silarx | LABELING | Approved |
| Fluoxetine Hydrochloride ANDA #078045 | Fluoxetine Hydrochloride | Capsule; Oral | SUPPL-9 | Mylan | LABELING | Approved |
| Fluoxetine Hydrochloride ANDA #079209 | Fluoxetine Hydrochloride | Solution; Oral | SUPPL-8 | Aurobindo Pharm | LABELING | Approved |
| Fluoxetine Hydrochloride NDA #202133 | Fluoxetine Hydrochloride | Tablet; Oral | SUPPL-4 | Edgemont Pharms Llc | LABELING | Approved |
| Fluoxetine Hydrochloride NDA #202133 | Fluoxetine Hydrochloride | Tablet; Oral | SUPPL-5 | Edgemont Pharms Llc | LABELING | Approved |
| Focalin NDA #021278 | Dexmethylphenidate Hydrochloride | Tablet; Oral | SUPPL-23 | Novartis | LABELING | Approved |
| Focalin Xr NDA #021802 | Dexmethylphenidate Hydrochloride | Capsule, Extended Release; Oral | SUPPL-33 | Novartis | LABELING | Approved |
| Khedezla NDA #204683 | Desvenlafaxine | Tablet, Extended Release; Oral | SUPPL-4 | Osmotica Pharm Corp | LABELING | Approved |
| Levetiracetam In Sodium Chloride ANDA #207160 | Levetiracetam | Injectable; Iv (Infusion) | ORIG-1 | Aurobindo Pharma Ltd | Approved | |
| Lexapro NDA #021323 | Escitalopram Oxalate | Tablet; Oral | SUPPL-47 | Forest Labs | LABELING | Approved |
| Lexapro NDA #021365 | Escitalopram Oxalate | Solution; Oral | SUPPL-35 | Forest Labs | LABELING | Approved |
| Luvox NDA #021519 | Fluvoxamine Maleate | Tablet; Oral | SUPPL-9 | Ani Pharms | LABELING | Approved |
| Luvox Cr NDA #022033 | Fluvoxamine Maleate | Capsule, Extended Release; Oral | SUPPL-11 | Jazz Pharms | LABELING | Approved |
| Metadate Cd NDA #021259 | Methylphenidate Hydrochloride | Capsule, Extended Release; Oral | SUPPL-30 | Ucb Inc | LABELING | Approved |
| Methylin NDA #021419 | Methylphenidate Hydrochloride | Solution; Oral | SUPPL-14 | Mallinckrodt | LABELING | Approved |
| Methylin NDA #021475 | Methylphenidate Hydrochloride | Tablet, Chewable; Oral | SUPPL-10 | Mallinckrodt | LABELING | Approved |
| Methylphenidate Hydrochloride ANDA #204115 | Methylphenidate Hydrochloride | Tablet, Chewable; Oral | SUPPL-3 | Novel Labs Inc | LABELING | Approved |
| Paxil NDA #020031 | Paroxetine Hydrochloride | Tablet; Oral | SUPPL-74 | Apotex Technologies | LABELING | Approved |
| Paxil NDA #020710 | Paroxetine Hydrochloride | Suspension; Oral | SUPPL-38 | Apotex Technologies | LABELING | Approved |
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