What's New Related to Drugs
Updated Monday through Friday:
October 2, 2020
- CDER Spotlight: Real-world Evidence from a Narrow Therapeutic Index Product (Levothyroxine) Reflects the Therapeutic Equivalence of Generic Drug Products
- Comunicado de la FDA sobre seguridad de los medicamentos: La FDA exige un Recuadro de advertencia actualizado para mejorar el uso seguro de los medicamentos de la clase de las benzodiazepinas
- FDA Drug Shortages
- Abacavir Sulfate and Lamivudine Tablets (New - Discontinuation)
- Cefazolin Injection (Updated - Currently in Shortage)
- Cefazolin Injection (Updated - Discontinuation)
- Lorazepam Injection, USP (Updated - Currently in Shortage)
Recent New and Generic Drug Approvals
This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.
October 2, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Sabril NDA #020427 | Vigabatrin | Tablet; Oral | SUPPL-24 | Lundbeck Pharms Llc | REMS | Approved |
| Sabril NDA #022006 | Vigabatrin | For Solution; Oral | SUPPL-25 | Lundbeck Pharms Llc | REMS | Approved |
| Azor NDA #022100 | Amlodipine Besylate; Olmesartan Medoxomil | Tablet; Oral | SUPPL-39 | Daiichi Sankyo | Labeling | Approved |
| Extavia BLA #125290 | Interferon Beta-1b | Injectable; Subcutaneous | SUPPL-70 | Novartis Pharms | Labeling | Approved |
| Yervoy BLA #125377 | Ipilimumab | Injectable; Injection | SUPPL-115 | Bristol Myers Squibb | Efficacy | Approved |
| Keytruda BLA #125514 | Pembrolizumab | Powder, For Injection Solution, Lyophilized Powder | SUPPL-70 | Merck Sharp Dohme | Efficacy | Approved |
| Opdivo BLA #125554 | Nivolumab | Injectable; Injection | SUPPL-89 | Bristol Myers Squibb | Efficacy | Approved |
| Tribenzor NDA #200175 | Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil | Tablet; Oral | SUPPL-33 | Daiichi Sankyo | Labeling | Approved |
| Vigabatrin ANDA #208218 | Vigabatrin | For Solution; Oral | SUPPL-11 | Par Pharm Inc | REMS | Approved |
| Vigabatrin ANDA #209822 | Vigabatrin | Tablet; Oral | SUPPL-8 | Teva Pharms Usa | REMS | Approved |
| Vigabatrin ANDA #209824 | Vigabatrin | For Solution; Oral | SUPPL-9 | Teva Pharms Usa | REMS | Approved |
| Vigabatrin ANDA #210155 | Vigabatrin | For Solution; Oral | SUPPL-10 | Amneal Pharms | REMS | Approved |
| Vigadrone ANDA #210196 | Vigabatrin | For Solution; Oral | SUPPL-7 | Aucta | REMS | Approved |
| Vigabatrin ANDA #211481 | Vigabatrin | For Solution; Oral | SUPPL-6 | Dr Reddys Labs Ltd | REMS | Approved |
| Vigabatrin ANDA #211592 | Vigabatrin | For Solution; Oral | SUPPL-4 | Invagen Pharms | REMS | Approved |
| Lampit NDA #213464 | Nifurtimox | Tablet; Oral | SUPPL-1 | Bayer Healthcare | Labeling | Approved |
| Vigabatrin ANDA #213469 | Vigabatrin | For Solution; Oral | SUPPL-1 | Granules Pharms | REMS | Approved |
October 1, 2020
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Rowasa NDA #019618 | Mesalamine | Enema; Rectal | SUPPL-26 | Mylan Speciality Lp | Labeling | Approved |
| Sfrowasa NDA #019618 | Mesalamine | Enema; Rectal | SUPPL-26 | Mylan Speciality Lp | Labeling | Approved |
| Asacol NDA #019651 | Mesalamine | Tablet, Delayed Release; Oral | SUPPL-28 | Apil | Labeling | Approved |
| Asacol NDA #019651 | Mesalamine | Tablet, Delayed Release; Oral | SUPPL-28 | Apil | Labeling | Approved |
| Pentasa NDA #020049 | Mesalamine | Capsule, Extended Release; Oral | SUPPL-33 | Takeda Pharms Usa | Labeling | Approved |
| Colazal NDA #020610 | Balsalazide Disodium | Capsule; Oral | SUPPL-23 | Valeant Pharms Intl | Labeling | Approved |
| Canasa NDA #021252 | Mesalamine | Suppository; Rectal | SUPPL-25 | Allergan | Labeling | Approved |
| Canasa NDA #021252 | Mesalamine | Suppository; Rectal | SUPPL-25 | Allergan | Labeling | Approved |
| Cymbalta NDA #021427 | Duloxetine Hydrochloride | Capsule, Delayed Rel Pellets; Oral | SUPPL-53 | Lilly | Labeling | Approved |
| Asacol Hd NDA #021830 | Mesalamine | Tablet, Delayed Release; Oral | SUPPL-16 | Apil | Labeling | Approved |
| Asacol Hd NDA #021830 | Mesalamine | Tablet, Delayed Release; Oral | SUPPL-16 | Apil | Labeling | Approved |
| Lialda NDA #022000 | Mesalamine | Tablet, Delayed Release; Oral | SUPPL-20 | Takeda Pharms Usa | Labeling | Approved |
| Giazo NDA #022205 | Balsalazide Disodium | Tablet; Oral | SUPPL-4 | Valeant Pharms Intl | Labeling | Approved |
| Apriso NDA #022301 | Mesalamine | Capsule, Extended Release; Oral | SUPPL-15 | Valeant Pharms Intl | Labeling | Approved |
| Topiramate ANDA #078235 | Topiramate | Tablet; Oral | SUPPL-20 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate ANDA #078235 | Topiramate | Tablet; Oral | SUPPL-23 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate ANDA #078235 | Topiramate | Tablet; Oral | SUPPL-24 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate ANDA #078235 | Topiramate | Tablet; Oral | SUPPL-25 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate ANDA #078235 | Topiramate | Tablet; Oral | SUPPL-29 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate ANDA #078235 | Topiramate | Tablet; Oral | SUPPL-20 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate ANDA #078235 | Topiramate | Tablet; Oral | SUPPL-21 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate ANDA #078235 | Topiramate | Tablet; Oral | SUPPL-23 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate ANDA #078235 | Topiramate | Tablet; Oral | SUPPL-24 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate ANDA #078235 | Topiramate | Tablet; Oral | SUPPL-25 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate ANDA #078235 | Topiramate | Tablet; Oral | SUPPL-29 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate ANDA #078877 | Topiramate | Capsule; Oral | SUPPL-13 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate ANDA #078877 | Topiramate | Capsule; Oral | SUPPL-15 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate ANDA #078877 | Topiramate | Capsule; Oral | SUPPL-16 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate ANDA #078877 | Topiramate | Capsule; Oral | SUPPL-17 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate ANDA #078877 | Topiramate | Capsule; Oral | SUPPL-20 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate ANDA #078877 | Topiramate | Capsule; Oral | SUPPL-12 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate ANDA #078877 | Topiramate | Capsule; Oral | SUPPL-13 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate ANDA #078877 | Topiramate | Capsule; Oral | SUPPL-15 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate ANDA #078877 | Topiramate | Capsule; Oral | SUPPL-16 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate ANDA #078877 | Topiramate | Capsule; Oral | SUPPL-17 | Zydus Pharms Usa Inc | Labeling | Approved |
| Topiramate ANDA #078877 | Topiramate | Capsule; Oral | SUPPL-20 | Zydus Pharms Usa Inc | Labeling | Approved |
| Alfuzosin Hydrochloride ANDA #079057 | Alfuzosin Hydrochloride | Tablet, Extended Release; Oral | SUPPL-18 | Sun Pharm | Labeling | Approved |
| Betaseron BLA #103471 | Interferon Beta-1b | Vial; Subcutaneous | SUPPL-5197 | Bayer Healthcare Pharms | Labeling | Approved |
| Dexlansoprazole ANDA #202294 | Dexlansoprazole | Capsule, Delayed Release; Oral | SUPPL-1 | Par Pharm Inc | Labeling | Approved |
| Dexlansoprazole ANDA #202294 | Dexlansoprazole | Capsule, Delayed Release; Oral | SUPPL-1 | Par Pharm Inc | Labeling | Approved |
| Delzicol NDA #204412 | Mesalamine | Capsule, Delayed Release; Oral | SUPPL-12 | Apil | Labeling | Approved |
| Delzicol NDA #204412 | Mesalamine | Capsule, Delayed Release; Oral | SUPPL-12 | Apil | Labeling | Approved |
| Acetazolamide ANDA #207401 | Acetazolamide | Capsule, Extended Release; Oral | ORIG-1 | Micro Labs Ltd India | Approved |
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