NEWS 30 AUG 2018

 

NEWS FROM USA

NDA Approvals        

DRUG	COMPANY	Brand Name	Press release if available
Eravacycline Injection	Tetraphase Pharms Inc	Xerava	Link
Doravirine Tablets	Merck	Pifeltro	Link
Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate Tablets	Merck	Delstrigo	Link

 

ANDA Approvals     

DRUG	COMPANY	Corresponding RLD	Press release if available
Gabapentin Tablets	Lupin	Neurontin (Pfizer)	Link
Docetaxel Injection	Cipla	Docetaxel (Hospira)
Ketorolac Tromethamine Tablets	Cycle Pharma	N/A	Link
Gemfibrozil Tablets	Zydus	LOPID (Pfizer)	Link
Aripiprazole Orally Disintegrating Tablets	Zydus	ABILIFY DISCMELT (BMS)	Link

 

 

Other news for USA

 

USFDA Accepts Bristol-Myers Squibb’s Application for Sprycel (dasatinib) in Pediatric Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

 

NEWS FROM EUROPE

European Commission approves Novartis combination therapy Tafinlar® + Mekinist for adjuvant treatment of BRAF V600 mutation-positive melanoma

                  

 

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NEWS 27 AUG 2018

 

NEWS FROM USA

NDA Approvals        

DRUG	COMPANY	Brand Name	Press release if available
Cenegermin-Bkbj Opthalmic Solution	Dompe	Oxervate	Link
Lanadelumab (Shp643) Injection	Dyax Corp	Takhzyro	Link

 

NEW GENERICS LAUNCHES IN US

 

DRUG	COMPANY	Corresponding RLD	Press Release
Drospirenone, Ethinyl Estradiol, Levomefolate Calcium Tablets	Lupin	Beyaz (Bayer’s )	Link

 

Other news for USA

 

Tetraphase Pharmaceuticals Announces FDA Approval of XERAVA (Eravacycline) for Complicated Intra-Abdominal Infections (cIAI)

 

 

NEWS FROM EUROPE

Ultragenyx Announces Approval of Mepsevii (vestronidase alfa) in Europe for the Treatment of Mucopolysaccharidosis VII   

Novartis receives European Commission approval of its CAR-T cell therapy, Kymriah (tisagenlecleucel)

         

 

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NEWS 24 AUG 2018

 

NEWS FROM USA

NDA Approvals        

DRUG	COMPANY	Brand Name	Press release if available
Loteprednol etabonate ophthalmic suspension	Kala Pharma	Inveltys	Link
Tretinoin topical lotion	Dow Pharma	Altreno

 

ANDA Approvals     

DRUG	COMPANY	Corresponding RLD	Press release if available
Ibuprofen tablets OTC	Aiping pharma	Motrin IB (J & J)
Aspirin/Dipyridamole ER capsules	Sun	Aggrenox (Boehringer)
Dexmedetomidine injection (4 mcg/ml) (First generic approval)	Baxter	Precedex (Hospira)
Cefepime lyo powder 100 gm in plastic container First approval for this strength	Samson	N/A
Clobetasol propionate ointment 0.05%	Amneal	N/A
Fluocinonide Cream 0.05%	Amneal	Fluocinonide (Taro)
Diphenydramine injection	Micro	N/A
Dexamethasone injection	Amneal	N/A
Emtricitabine and Tenofovir disoproxil fumarate tablets (First generic approval)	Amneal	Truvada (Gilead)
Neostigmine methylsulfate IV solution	Renaissance	Bloxiverz (Avadel)

 

Tentative Approvals           

DRUG	COMPANY	Corresponding RLD	Press release if available
Bortezomib injection	Mylan	Velcade (Millenium)

 

 

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NEWS 22 AUGUST 2018

 

NEWS FROM USA

NDA Approvals        

DRUG	COMPANY	Corresponding RLD	Press release if available
Stiripentol Capsule	Biocodex SA	N/A	Link
Stiripentol Powder	Biocodex SA	N/A	Link

 

ANDA Approvals     

DRUG	COMPANY	Corresponding RLD	Press release if available
Ranitidine Tablets	Granules India	Zantac (Sanofi)	Link
Hydrocortisone butyrate lotion, 1.0%	Lupin	Locoid	Link

 

Tentative Approvals           

DRUG	COMPANY	Corresponding RLD	Press release if available
Estradiol Valerate Tablets & Estradiol Valerate and Dienogest Tablets	Lupin	Natazia (Bayer)	Link

 

NEW GENERICS LAUNCHES IN US

 

DRUG	COMPANY	Corresponding RLD	Press Release
Clobetasol Propionate Cream	Lupin	Temovate (Fougera Pharmaceuticals)	Link

 

 

Other News from USA

Strides receives acceptance from USFDA for two key ANDAs under newly introduced Competitive Generic Therapy

 

News from JAPAN

Tagrisso approved in Japan for 1st-line treatment of EGFR-mutated non-small cell lung cancer

 

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NEWS 08 AUG 2018

 

NEWS FROM USA

NDA Approvals        

DRUG	COMPANY	Corresponding RLD	Press release if available
Tigecycline Injectable	Amneal Pharms	N/A	Link
Mogamulizumab-Kpkc Injectable	Kyowa kirin	N/A	Link

 

ANDA Approvals     

DRUG	COMPANY	Corresponding RLD	Press release if available
Methadone Hydrochloride Tablets	Elite Labs	Dolophine Hydrochloride (West-Ward)
Tadalafil Tablets	Mylan Pharms	Adcirca (Eli Lilly )
Lidocaine Hydrochloride	B Braun Medical	Xylocaine (Fresenius Kabi)
Diclofenac Sodium Topical	Cipla	Voltaren (GSK)

 

 

Tentative Approvals           

DRUG	COMPANY	Corresponding RLD	Press release if available
Bimatoprost	Alembic	N/A

 

Other News from USA

FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs

 

Glenmark Pharmaceuticals Announces FDA Acceptance of the Company’s First New Drug Application for Ryaltris for Patients with Seasonal Allergic Rhinitis

 

Glenmark Pharmaceuticals’ partner Elite Pharmaceuticals receives US FDA approval for generic methadone hydrochloride tablet

 

 

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