NEWS 08 APR 2019

NEWS FROM USA

Paragraph IV filing

DRUG	Dosage form	Corresponding RLD	Date of Submission	Type of Submission (Based on Date)
Canagliflozin And Metformin Hydrochloride	ER Tablets	Invokamet XR	21 Nov 2018	Post NCE-1

 

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Capecitabine Tablets	Armas pharma	Xeloda	$108 Million	Link
Imatinib Tablets	Armas Pharma	Gleevec	$655 Million	Link
Albuterol sulphate  Aerosol	Endo	Proventil	N/A	Link

 

NDA Approvals

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
03 Apr 2019	Colesevelam Hydrochloride Oral Bar	Daiichi Sankyo	Welchol	Link

 

ANDA Approvals

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
02 Apr 2019	Selegiline Hydrochloride Capsules	Pack Pharms	Eldepryl (Somerset)	Two
02 Apr 2019	Bupivacaine hydrochloride Injectable	B Braun	Marcaine (Hospira)	Two
02 Apr 2019	Carmustine Injection	Sti Pharma	Bicnu (Emcure)	Two
03 Apr 2019	Estradiol; Norethindrone Acetate Tablets	Novast Labs	Activella (Amneal)	Four
03 Apr 2019	Permethrin Cream	Encube Ethicals	Elimite (Mylan)	Two
03 Apr 2019	Fluocinonide Cream	Teligent Pharma	Vanos (Medicis)	Five
04 Apr 2019	Losartan Potassium Tablets	Hisun Pharm	Cozaar (Merck)	More Than 10
04 Apr 2019	Pitavastatin Calcium Tablets	Mylan	Livalo (Kowa)	Three
04 Apr 2019	Olopatadine Hydrochloride Solution	Aurobindo	Pataday (Novartis)	Four

 

Tentative ANDA Approvals

Approval Date	Drug	Company
02 Apr 2019	Fingolimod	Hec Pharm
05 Apr 2019	Lacosamide	Zydus Pharms
05 Apr 2019	Tofacitinib Citrate	Zydus Pharms
08 Apr 2019	Bortezomib	Shilpa Medicare

 

Other News from the USA

Sun Pharma Launches Ready-to-Infuse INFUGEM in the U.S

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