NEWS 29 April 2019

NEWS FROM USA

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Cefazolin injections (10 GM/vial)	Apotex	Ancef	N/A	Link

 

NDA APPROVALS (New combination)

 

Approval Date	Product Name	NDA Sponsor	Brand Name	Prescribing information
25 Apr 2019	Halobetasol Propionate (0.01%)/Tazarotene (0.045%) lotion	Bausch	Duobrii	Link

 

ANDA APPROVALS

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
23 Apr. 2019	Rufinamide oral suspension	Bion pharma	Banzel (Eisai)	None
		Hikma
24 Apr. 2019	Testosterone Cypionate injections	Wilshire pharma	Depo-Testosterone (RS)	Eight
24 Apr. 2019	Rosuvastatin Calcium tablets	Sciegen pharma	Crestor (IPR)	More than 20
24 Apr. 2019	Cisatracurium besylate injections	Somerset therapeutics	Nimbex (Abbvie)	Four
24 Apr. 2019	Pentamidine isethionate inhalant	Seton Pharma	Nebupent* (Fresenius Kabi)	None
24 Apr. 2019	Teriflunomide Tablets	MSN	Aubagio (Sanofi)	Six
24 Apr. 2019	Medroxyprogesterone acetate injections	Sun Pharma	Depo-Provera (Pharmacia)	Four
24 Apr. 2019	Methylphenidate ER tablets	Andor Pharma	Concerta (Janssen)	Six
24 Apr. 2019	Leflunomide tablets	Zydus	Arava (Sanofi)	Five
25 Apr. 2019	Daunorubicin injections	Hisun Pharma	Cerubidine (West-Ward)	Fresenius Kabi
25 Apr. 2019	Linezolid tablets	Celltrion	Zyvox (Pharmacia)	Ten
25 Apr. 2019	Cisatracurium besylate injections	Nanjing-King friend	Nimbex (Abbvie)	Four
25 Apr. 2019	Cisatracurium besylate injections preservative free	Nanjing-King friend	Nimbex Preservative free (Abbvie)	Four
25 Apr. 2019	Clarithromycin tablets	Ajanta	Biaxin (Tablets)	Eight

*Nebupent was mentioned in FDA’s latest off-patent off-exclusivity products without an approved generic list. 

USFDA INSPECTIONS:

Torrent Pharma provides update on USFDA audit at Indrad plant.

-      The inspection was conducted by USFDA in April 2019.

-      As per the press release, the Indrad facility has received certain observations which are procedural in nature and the Company is confident of addressing them satisfactorily.

-      Full Press release: Link

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