NEWS 07 FEB 2019

NEWS FROM USA

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
04 Feb 2019	Acyclovir Cream	Perrigo	Zovirax (Vib)	This Product Was Mentioned In FDA’s Off Patent Off Exclusivity Product With No Generic List
04 Feb 2019	Levomilnacipran Hydrochloride ER Capsule	Amneal Pharms	Fetzima (Allergan)	None
04 Feb 2019	Oxycodone Hydrochloride Solution	Alkem Labs	Oxycodone Hydrochloride (Genus)	More Than 10
05 Feb 2019	Levofloxacin Tablets	HEC Pharm	N/A	More Than 10
05 Feb 2019	Tadalafil Tablets	Hetero Labs	Adcirca (Eli Lilly)	Six
05 Feb 2019	Tadalafil Tablets	Dr Reddys
05 Feb 2019	Tadalafil Tablets	Cipla
05 Feb 2019	Tadalafil Tablets	Ajanta Pharma
05 Feb 2019	Tadalafil Tablets	Lupin
05 Feb 2019	Estradiol ER Transdermal Film	Amneal	Vivelle-Dot (Novartis)	One (Mylan)

*Highlighted product indicates first generic approval for the corresponding RLD.

 

Tentative ANDA Approvals 

Approval Date	Drug	Company
6 Feb. 2019	Tadalafil Tablets	Aurobindo
07 Feb 2019	Fulvestrant Injection	Glenmark

 

 

 

 

 

 

NEW GENERICS LAUNCHES IN THE US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Hydrocodone Apap Tablets	Camber Pharma	Norco (Warner Chilcott)	N/A	Link
Tadalafi Tablets	Teva Pharma	Adcirca (Eli Lilly)	$490 Million	Link
Vigabatrin Tablets	Teva Pharma	Sabril (Lundbeck)	$180 Million	Link

 

USFDA Inspection

USFDA issues observations to Lupin’s pithampur unit

US FDA Inspection at Alkem's manufacturing facility located at St Louis, USA.

Strides pharma science gets EIR for Bangalore facility

 

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