NEWS 26 FEB 2019

NEWS FROM THE USA 

505(b)2S in Pipeline

Diroximel Fumarate (Alkermes And Biogen): Alkermes And Biogen announce USFDA acceptance of Diroximel Fumarate NDA for Multiple Sclerosis.

NEW GENERICS LAUNCHES IN THE US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Minocycline Hydrochloride ER Tablets	Lupin	Solodyn (Medicis Pharma)	$76.8 Millions	Link

 

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
21 Feb 2019	Calcitriol Capsules	Sun Pharm	Rocaltrol (Validus)	Five
21 Feb 2019	Aripiprazole Tablets	Alkem Labs	Abilify (Otsuka)	More Than 10
21 Feb 2019	Exemestane Tablets	Breckenridge	Aromasin (Pharmacia And Upjohn)	Seven
22 Feb 2019	Niacin ER Tablets	Mylan Pharms	Niaspan (Abbvie)	Seven
22 Feb 2019	Meclizine Hydrochloride Tablets	Indicus	N/A	Six
22 Feb 2019	Gemcitabine Hydrochloride Injection	Shilpa Medicare	Gemzar (Lilly)	More Than 10
22 Feb 2019	Methylprednisolone Tablets	Lupin	Medrol (Pharmacia And Upjohn)	Seven
22 Feb 2019	Busulfan Injection	Accord Hlthcare	Busulfex (Otsuka)	Nine
22 Feb 2019	Olmesartan Medoxomil Tablets	Sunshine	Benicar (Daiichi)	More Than 10
22 Feb 2019	Benzonatate Capsule	Ascent Pharms	Tessalon (Pfizer)	More Than 10
22 Feb 2019	Clofarabine Solution	Accord	Clolar (Genzyme)	Eight

 

Tentative ANDA Approvals 

Approval Date	Drug	Company
21 Feb 2019	Dimethyl Fumarate	Hetero Labs

 

 

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