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Thursday, July 26, 2018

NEWS 26 JULY 2018

 

NEWS FROM USA

ANDA Approvals     

DRUG

COMPANY

Corresponding RLD

Press release if available

Ethacrynic Acid Tablets

Alvogen

Edecrin (Aton)

 

Dorzolamide Hydrochloride; Timolol Maleate Drops

Aurobindo 

Cosopt (Oak Pharma)

 

 

 

NEWS FROM INDIA

New Biosimilar approval

DRUG

COMPANY

LABEL

Hervycta (Trastuzumab)

 

Biosimilar to Herceptin

DR Reddy

Prescribing Information

 

 

If you have any query/suggestion then please write us at pharmacaption@gmail.com


 

Wednesday, July 25, 2018

NEWS 25 JULY 2018

 

NEWS FROM USA

NDA Approvals

DRUG

COMPANY

LABEL

Ivosidenib tablets

 

Approval date: 20 july 2018

Agios pharmaceuticals 

Prescribing Information

Elagolix sodium Tablet

Approval date: 23 july 2018

Abbvie inc

Prescribing Information

Doxercalciferol Injection

Approval date: 24 july 2018

Hospira

Prescribing Information

 

ANDA Approvals     

DRUG

COMPANY

Corresponding RLD

Press release if available

Hydrocortisone cream

Teligent

N/A

 

Sodium chloride injection

Fresenius kabi 

Sodium chloride 0.45% in plastic container  (B Braun)

 

Nadolol tablets

Beximco 

Corgard (US worldmeds)

 

 

NEW GENERICS LAUNCHES IN US

 

DRUG

COMPANY

Corresponding RLD

Press Release

Metformin hydrochloride ER tablets

Sun Pharma

Glumetza

Link

 

 

If you have any query/suggestion then please write us at pharmacaption@gmail.com


 

 

Tuesday, July 24, 2018

NEWS 24 JULY 2018

 

NEWS FROM USA

NDA Approvals

DRUG

COMPANY

LABEL

Tafenoquine tablets

 

NCE

 

Approval Date: 20 July 2018

GSK

Prescribing Information


New Biosimilar approval

DRUG

COMPANY

LABEL

Nivestym (Filgrastim-aafi)

 

Biosimilar to Neupogen

Hospira

Prescribing Information

 

ANDA Approvals     

DRUG

COMPANY

Corresponding RLD

Press release if available

Acetylcysteine injection

Zydus

Acetadote

Link

Sumatriptan; Naproxen tablets

Sun Pharma

Treximet

 

Gemcitabine injection

Sagent

Gemcitabine (Hospira)

 

Cetirizine HCl Allergy

Aurobindo

Cetirizine

(Biopharma)

 

Cetirizine HCl hives relief

Aurobindo

Cetirizine

(Biopharma)

 

Pyridostigmine Tablet

Invatech

Mestinon

 

 

Tentative ANDA Approvals

DRUG

COMPANY

Corresponding RLD

Oxcarbazepine

Actavis

N/A


 

NEW GENERICS LAUNCHES IN US

 

DRUG

COMPANY

Corresponding RLD

Press Release

Metformin ER tablets

Beximco pharma

Glocophage

Link

Potassium chloride oral solution

Amneal

Potassium chloride

(Genus lifesciences)

Link

 

OTHER NEWS FROM USA

 

Aerie Pharmaceuticals Announces Early Notification of FDA Acceptance of NDA Submission for Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% with PDUFA Date Set for March 14, 2019

 

NEWS FROM EUROPE

NEW GENERICS LAUNCHES IN GERMANY

 

DRUG

COMPANY

Generic equivalent of

Press Release

Pemetrexed RTU

Stada

Alimta

Link

 

If you have any query/suggestion then please write us at pharmacaption@gmail.com

Friday, July 20, 2018

NEWS 20 JULY 2018

 

NEWS FROM USA

NDA Approvals

DRUG

COMPANY

LABEL

Gemcitabine Injection

10 mg/ml

 

New Dosage Form

 

Approval Date: 16 July 2018

Sun Pharma

Prescribing Information

Darunavir,

Cobicistat,

Emtricitabine,

Tenofovir Alafenamide

 

New Combination

 

Approval Date: 17 July 2018

Janssen 

Prescribing Information

Ivosidenib

 

Approval Date: 20 July 2018

Agios

Prescribing Information

 


ANDA Approvals
     

DRUG

COMPANY

Corresponding RLD

Press release if available

Olanzapine Tablets

Zydus

Zyprexa

Glipizide ER Tablets

Zydus

Glucotrol Xl

Voriconazole  Injection

Zydus

Vfend

Fluocinonide Topical Solution

Zydus

Lidex

Piroxicam Capsules

Zydus

Feldene

Spironolactone Tablets

Zydus

Aldactone

Gemcitabine Injection

Sun Pharma

Infugem

Bivalirudin Injection

Sagent

Angiomax

 

Dexchlorpheniramine Maleate Syrup

Capellon

N/A

 

Morphine Sulfate Injection

Piramal

Infumorph

 

Guaifenesin Tablet

Ohm Labs

Mucinex

 

Dextrose Injection

Fresenius Kabi

Dextrose 10% In Plastic Container

 

Ethinyl Estradiol; Norethindrone Acetate Tablet

Chemo Research

Minastrin 24 Fe

 

 

Sodium Nitroprusside Injection

Cipla

N/A

 

Cytarabine Injection

Hong Kong

N/A

 

Asenapine Maleate Tablet

Sigmapharm

Saphris

 

 

Tentative ANDA Approvals

DRUG

COMPANY

Corresponding RLD

Tadalafil Tablets

Lupin

Cialis

Solifenacin Succinate

Cipla

Vesicare

Palonosetron Hydrochloride

Virtus Pharm

Aloxi

 

 

Palonosetron Hydrochloride

Mylan

Aloxi


 

NEW GENERICS LAUNCHES

 

DRUG

COMPANY

Corresponding RLD

Press Release

Esomeprazole Magnesium Capsule

Dr Reddy

Nexium 24 HR

 

OTHER NEWS FROM USA

 

Ocular therapeutix announces FDA acceptance of NDA resubmission for dextenza (dexamethasone insert)

If you have any query/suggestion then please write us at pharmacaption@gmail.com