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)

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