NEWS 01 MAR 2019

NEWS FROM THE USA 

NEW GENERICS LAUNCHES IN THE US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Ranolazine ER Tablets	Lupin	Ranexa ER (Gilead)	$945 Millions	Link

 

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
25 Feb 2019	Metronidazole Injection	Inforlife	Metronidazole In Plastic Container (Hospira)	Two
25 Feb 2019	Omega-3-Acid Ethyl Esters Capsule	Ascent	Lovaza (Smithkline Beecham)	Five
25 Feb 2019	Abiraterone Acetate Tablets	Rising Pharms	Zytiga (Janssen)	Five
26 Feb 2019	Azithromycin Tablets (Eq 250mg Base)	Bionpharma	Zithromax (Pfizer)	Seven
26 Feb 2019	Azithromycin Tablets (Eq 500mg Base)	Bionpharma	Zithromax (Pfizer)	Eight
26 Feb 2019	Chlorthalidone Tablets	Invatech	N/A	Five
27 Feb 2019	Azacitidine Powder	Lupin	Vidaza (Celgene)	Seven
27 Feb 2019	Oseltamivir Phosphate Oral Suspension	Teva Pharms	Tamiflu (Roche)	Four

 

Tentative ANDA Approvals 

Approval Date	Drug	Company
27 Feb 2019	Esomeprazole Magnesium;Naproxen	Anchen

 

 

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