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RA Update 2020-04 Flipbook PDF
RA Update 2020-04
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Issue # 94 April 2020 May
NDA/BLA APPROVALS New Approvals………… Page 1 Citizen Petitions……….. Page 2 Patents Listed…...…….. Page 3 FDA Guidance Generic Approvals…….. Page 4 Tentative Approvals....... Page 7 Drug Shortages.............. Page 8 1st Time Generics
April Highlights Date
Active Ingredient
Company
KOSELUGO NDA #213756 JELMYTO NDA #211728
SELUMETINIB SULFATE
EMERPHED NDA #213407
EPHEDRINE SULFATE
NEXUS PHARMS
TUKYSA NDA #213411
TUCATINIB
SEATTLE GENETICS
PEMAZYRE NDA #213736
PEMIGATINIB
INCYTE CORP
TRODELVY BLA #761115
SACITUZUMAB GOVITECAN-HZIY
IMMUNOMED ICS INC
ONGENTYS NDA #212489
OPICAPONE
NEUROCRIN E
04/28/2020
505b2 DR capsule for MS
BAFIERTAM NDA #210296
MONOMETHYL FUMARATE
BANNER LIFE SCIENCES
04/29/2020
505b2 vaginal system for infertility
MILPROSA NDA #201110
PROGESTERONE
FERRING PHARMS INC
04/15/2020 04/17/2020
04/17/2020 04/22/2020 04/24/2020
65 total ANDAs approved by FDA in April 2020
Drug Name
NCE capsule for neurofibromatosis 505b2 injection for urothelial cancer 505b2 injection for hypotension in anesthesia NCE tablet for HER-2 positive breast cancer NCE tablets for cholangiocarcinom a BLA for breast cancer NCE capsule for Parkinson’s Disease
04/10/2020
04/17/2020
65
Indication / Comments
MITOMYCIN
ASTRAZENE CA PHARMS UROGEN PHARMA
This month FDA approved 5 more ANDAs than in March 2020.
1
Citizen Petitions Petitioner
Product Name/Issue
Category
Petition Type
Date
Fresenius KabiUSA, LLC
Acetaminophen Injection 10 mg/mL
Drug
Citizen Petition
04/02/2020
Designate TE code of AP
Foley & Lardner LLP
ALCAINE (Proparacaine Hydrochloride) Ophthalmic Solution 0.5%
Drug
Citizen Petition RLD designation
04/06/2020
Designate ALCAINE (Proparacaine Hydrochloride) Ophthalmic Solution 0.5%, by Alcon Laboratories Inc. as an additional RS
Foley & Lardner, LLP
Lidocaine Hydrochloride Injection USP, 20mg /2mL (10mg/mL)
Drug
Citizen Petition ANDA Suitability Petition
04/06/2020
Suitability of new fill size 2 mL
04/23/2020
Revoke/withdraw the EUA for hydroxychloroquine and any identical, similar, or related drug products
04/28/2020
Request FDA not to permit companies to carve out of the labeling currently approved for Lonsurf®, language relating to dose reductions in severely renally impaired patients
Dr. Albert Edwards Foley & Lardner LLP on behalf of Taiho Oncology, Inc.
Hydroxychloroquine
Lonsurf ® Tablets (trifluridine/tipiracil)
Drug
Citizen Petition
Drug
Citizen Petition (505(q) Certification)
Summary
2
Newly Listed Patents Active Ingredient / Brand Name
Patent
Patent Expire
Submission Date
110
10/27/2030
3/17/2020
688
5/11/2031
5/6/2020
861 054 510 511
6/28/2033 6/28/2033 1/25/2033 10/10/2034
3/20/2020 3/27/2020 5/8/2020 5/8/2020
CABAZITAXEL (JEVTANA KIT) CANAGLIFLOZIN (INVOKANA) ICOSAPENT ETHYL (VASCEPA) TASIMELTEON (HETLIOZ)
New Guidance Category
Title
Type
Date
User Fees
Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act
Final
04/03/2020
Clinical / Medical
Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry
Final
04/10/2020
Clinical / Medical
Product-Specific Guidances for Chloroquine Phosphate and Hydroxychloroquine Sulfate
Final
04/13/2020
Compounding
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency
Final
04/16/2020
Compounding, Pharmaceutical Quality
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry
Final
04/20/2020
Combination Products
Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA
Draft
04/21/2020
Compounding, Clinical Medical
Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency Guidance for Industry
Final
04/30/2020
3
ANDA Approvals April 2020 Approval Date 04/01/2020 04/01/2020 04/01/2020 04/02/2020 04/03/2020 04/03/2020 04/03/2020 04/06/2020 04/06/2020 04/06/2020 04/06/2020 04/07/2020 04/07/2020 04/07/2020 04/07/2020 04/07/2020 04/08/2020 04/08/2020 04/08/2020 04/08/2020 04/08/2020
Drug Name ESOMEPRAZOLE SODIUM ANDA #203349 LAMOTRIGINE ANDA #207763 ROSUVASTATIN CALCIUM ANDA #210667 HEPARIN SODIUM PRESERVATIVE FREE ANDA #212060 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE ANDA #210293 CLOMIPRAMINE HYDROCHLORIDE ANDA #210653 MEMANTINE HYDROCHLORIDE ANDA #212947 PERPHENAZINE ANDA #205232 TICAGRELOR ANDA #208508 CHOLESTYRAMINE ANDA #211119 OXYBUTYNIN CHLORIDE ANDA #212798 TICAGRELOR ANDA #208596 FINZALA ANDA #210087 ACYCLOVIR ANDA #212495 AMITRIPTYLINE HYDROCHLORIDE ANDA #212654 HYDROXYCHLOROQUINE SULFATE ANDA #213342 ALBUTEROL SULFATE ANDA #209959 APIXABAN ANDA #210152 IMATINIB MESYLATE ANDA #210658 FLUOXETINE HYDROCHLORIDE ANDA #213286 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ANDA #213321
04/08/2020
HYDROXYUREA ANDA #213438
Dosage Form
Company
Total Active Generics with TE
i.v. Injectable
GLAND PHARMA LTD
6
ER Tablet
ZYDUS PHARMS
9
Tablet
SUNSHINE LAKE
20
Injection
NANJING KINGFRIEND
7
Tablet
BIONPHARMA INC
13
Capsule
TULEX PHARMS INC
11
Tablet
NINGBO
21
Tablet
ZYDUS PHARMS
8
Tablet
HEC PHARM CO LTD
3
Oral Powder
AJANTA PHARMA LTD
9
Tablet Tablet Chewable Tablet Topical Ointment
LEADING PHARMA LLC SIGMAPHARM LABS LLC TEVA PHARMS USA INC SOLARIS PHARMA CORP
11 3 4 14
Tablet
UPSHER SMITH LABS
7
Tablet
ACCORD HLTHCARE
13
Metered Inhalation
CIPLA
1
Tablet
BIONPHARMA INC
2
Tablet
ZYDUS PHARMS
11
Tablet
AUROBINDO PHARMA LTD
9
Capsule
GRANULES PHARMS
6
Capsule
LEADING PHARMA LLC
3
Apotex ANDA
4
Approval Date 04/09/2020 04/09/2020 04/09/2020 04/10/2020 04/10/2020 04/13/2020 04/13/2020 04/13/2020 04/13/2020 04/14/2020 04/15/2020 04/15/2020 04/16/2020 04/16/2020 04/17/2020 04/17/2020 04/17/2020
04/17/2020
04/20/2020 04/20/2020 04/21/2020 04/21/2020
Drug Name ROPIVACAINE HYDROCHLORIDE ANDA #212808 SEVELAMER CARBONATE ANDA #212970 METFORMIN HYDROCHLORIDE ANDA #213651 METHYLPHENIDATE HYDROCHLORIDE ANDA #210764 RAMELTEON ANDA #212650 OLMESARTAN MEDOXOMIL ANDA #090237 IVERMECTIN ANDA #210225 SOLIFENACIN SUCCINATE ANDA #213346 EXEMESTANE ANDA #213547 BUPRENORPHINE ANDA #211586 CHABELINA FE ANDA #202962 CARBAMAZEPINE ANDA #207798 TESTOSTERONE ANDA #210835 ERLOTINIB HYDROCHLORIDE ANDA #213065 BUPROPION HYDROCHLORIDE ANDA #207403 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #211785 FLUCYTOSINE ANDA #212632 BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ANDA #213125 ALBUTEROL SULFATE ANDA #211888 COLESEVELAM HYDROCHLORIDE ANDA #212602 ESTRADIOL VALERATE ANDA #203723 CLOCORTOLONE PIVALATE ANDA #206370
Dosage Form
Company
Total Active Generics with TE
Injection
CAPLIN
7
Tablet
ANXIN
8
ER Tablet
AJANTA PHARMA LTD
6
Oral Solution
PATRIN PHARMA INC
7
Tablet
I3 PHARMS
4
Tablet
SANDOZ INC
16
Topical Cream
PERRIGO UK FINCO
2
Tablet
SUNSHINE LAKE
18
Tablet
QILU
8
ER Transdermal Film
AMNEAL PHARMS LLC
2
Tablet
NOVAST LABS
3
Tablet
UMEDICA LABS PVT LTD
5
Transdermal Metered Gel
XIROMED
7
Tablet
ZYDUS PHARMS
7
Tablet
MICRO LABS
8
Sublingual Film
MYLAN TECHNOLOGIES
3
Capsule
STRIDES PHARMA
6
Syrup
LANNETT CO INC
6
Inhalation Solution
AUROBINDO PHARMA LTD
3
Tablet
INVAGEN PHARMS
7
Injection
HIKMA
2
Topical Cream
TARO
1
5
Approval Date 04/22/2020 04/22/2020 04/23/2020 04/23/2020 04/23/2020 04/23/2020 04/24/2020 04/24/2020 04/24/2020 04/24/2020 04/24/2020 04/27/2020 04/27/2020 04/28/2020 04/28/2020 04/28/2020 04/29/2020 04/29/2020 04/30/2020 04/30/2020 04/30/2020
Drug Name LEVOFLOXACIN ANDA #205540 HYDROMORPHONE HYDROCHLORIDE ANDA #207108 SILDENAFIL CITRATE ANDA #205791 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER ANDA #211968 ACYCLOVIR ANDA #212718 TROSPIUM CHLORIDE ANDA #213185 DEFERASIROX ANDA #209223 CARBAMAZEPINE ANDA #211623 EPINEPHRINE ANDA #211880 CLOBAZAM ANDA #213110 VIGABATRIN ANDA #213469 MUPIROCIN ANDA #207116 CAPECITABINE ANDA #211724 DILTIAZEM HYDROCHLORIDE ANDA #206997 GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE ANDA #212542 PENICILLAMINE ANDA #213310 OXYCODONE HYDROCHLORIDE ANDA #205853 LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #213513 ACETAZOLAMIDE ANDA #207503 LIDOCAINE ANDA #209190 OMEPRAZOLE AND SODIUM BICARBONATE ANDA #212587
Dosage Form
Company
Total Active Generics with TE
Injection
GLAND PHARMA LTD
4
Oral Solution
LANNETT CO INC
3
Tablet
PERRIGO R AND D
11
Injection
NEPHRON
7
Oral Suspension
HERITAGE PHARMS INC
3
ER Capsule
GRANULES PHARMS
3
Tablet
TEVA PHARMS USA
10
ER Tablet
UNIQUE PHARM
3
i.m, i.v., s.c. Solution
INTL MEDICATION SYS
1
Oral Suspension
LANNETT CO INC
10
For Solution
GRANULES PHARMS
7
Topical Cream
TARO
2
Tablet
RELIANCE LIFE
11
ER Capsule
ACCORD HLTHCARE
2
ER Tablet (OTC)
SUN PHARM INDS INC
4
Capsule
APOTEX
4
Oral Solution
RHODES PHARMS
12
Tablet (OTC)
HETERO LABS LTD III
4
Tablet
BRECKENRIDGE
7
Topical Patch
RHODES PHARMS
3
Capsule
GUARDIAN DRUG
6
6
Tentative Approvals April 2020 Approval Date(s) 04/02/2020 04/03/2020 04/07/2020 04/08/2020 04/08/2020 04/09/2020 04/09/2020 04/09/2020 04/09/2020 04/13/2020 04/13/2020 04/14/2020 04/14/2020 04/15/2020 04/17/2020
Drug Name ALCAFTADINE ANDA #209706 METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE ANDA #206081 FINGOLIMOD ANDA #210252 MACITENTAN ANDA #211187 PALBOCICLIB ANDA #213093 DAPAGLIFLOZIN; SAXAGLIPTIN ANDA #211492 DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE ANDA #211563 EMPAGLIFLOZIN ANDA #212138 ACETAMINOPHEN; BUTALBITAL; CAFFEINE ANDA #212800 MACITENTAN ANDA #211026 DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE NDA #211912 MACITENTAN ANDA #211120 MACITENTAN ANDA #211224 PHENYLEPHRINE; KETOROLAC ANDA #213515 ALCAFTADINE ANDA #209290
Company GLAND PHARMA LTD SUN PHARM INDS LTD BIONPHARMA INC TEVA PHARMS USA INC QILU PHARM CO LTD SUN PHARM INDS LTD ALKEM LABS LTD ZYDUS PHARMS USA ABHAI INC SEASONS BIOTECHNOLOGY (TAIZHOU) CO LTD CELLTRION INC LAURUS LABS LTD ZYDUS WORLDWIDE DMCC GLAND PHARMA LTD ALEMBIC PHARMS LTD
04/17/2020
CINACALCET ANDA #211892
ACCORD HLTHCARE INC
04/20/2020
BENDAMUSTINE HYDROCHLORIDE ANDA #211001
NANJING KING-FRIEND
04/24/2020
LURASIDONE HYDROCHLORIDE ANDA #212091
PIRAMAL HLTHCARE UK
04/27/2020
DAPAGLIFLOZIN; SAXAGLIPTIN ANDA #211565
GLENMARK GENERICS
04/28/2020
ARFORMOTEROL TARTRATE ANDA #213068
LUPIN
04/30/2020 04/30/2020
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE ANDA #212198 EMPAGLIFLOZIN ANDA #212283
ZYDUS PHARMS USA INC MANKIND PHARMA
7
Current Drug Shortages Drug Name
Apotex Status
Shortage Impact
Cefazolin Injection
Active product
6 manufacturers reporting shortage
Cefepime Injection
Active product
5 manufacturers reporting shortage
Cefoxitin for Injection, USP
Temporarily Discontinued
6 manufacturers reporting shortage
Famotidine Tablets
Inactive Product
3 manufacturers reporting shortage
Ketorolac Tromethamine Injection
Inactive Product
7 manufacturers reporting shortage
Levetiracetam Extended-Release Oral Tablets, USP
Active product
4 manufacturers reporting shortage
Nizatidine Capsules
Inactive Product
2 manufacturers reporting shortage
Ondansetron Hydrochloride Injection
Active product
6 manufacturers reporting shortage
First-time Generic Drug Approvals Generic Drug Name
Generic Manufacturer(s)
Brand Name
Approval Date
Carfilzomib for Injection, 30 mg SingleDose Vial
Apotex Inc.
Kyprolis (Carfilzomib) for Injection, 30 mg Single-Dose Vial
03/20/2020
Esomeprazole Magnesium DelayedRelease for Oral Suspension, 20 mg, 40 mg
Cipla Limited
Nexium (Esomeprazole Magnesium) DelayedRelease for Oral Suspension, 20 mg, 40 mg
03/23/2020
Esomeprazole Magnesium DelayedRelease for Oral Suspension, 10 mg
Cipla Limited
Nexium (Esomeprazole Magnesium) DelayedRelease for Oral Suspension, 10 mg
03/23/2020
8