NEWS 29 MAR 2019

NEWS FROM USA

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Tadalafil Tablets	Dr Reddys	Cialis (Eli Lilly)	$1.7 Billion	Link
	Zydus			Link
Fluocinonide Ointment	Lupin	Lidex (County Line Pharma)	$15 Million	Link

 

NDA Approvals                    

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
27 Mar 2019	Siponimod	Novartis	Mayzent	Link
27 Mar 2019	Testosterone Undecanoate Capsules	Clarus Therapeutics	Jatenzo	Link

 

ANDA Approvals

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
26 Mar 2019	Entecavir Tablets	Mylan	Baraclude (BMS)	More Than 10
26 Mar 2019	Aspirin And Extended-Release Dipyridamole Capsules	Lannett	Aggrenox (Boehringer)	Eight
26 Mar 2019	Tadalafil Tablets	Unichem Lab	Cialis (Eli Liiiy)	More Than 10
26 Mar 2019	Tadalafil Tablets	Alembic Pharma
26 Mar 2019	Tadalafil Tablets	Lupin
26 Mar 2019	Tadalafil Tablets	Aurobindo Pharma
26 Mar 2019	Tadalafil Tablets	Sun Pharma
26 Mar 2019	Tadalafil Tablets	Accord Healthcare
26 Mar 2019	Tadalafil Tablets	Cipla
26 Mar 2019	Tadalafil Tablets	Ajanta Pharma
26 Mar 2019	Tadalafil Tablets	Amneal
26 Mar 2019	Tadalafil Tablets	Hetero
26 Mar 2019	Tadalafil Tablets	Qilu
26 Mar 2019	Tadalafil Tablets	Sunshine Lake
26 Mar 2019	Tadalafil Tablets	Torrent
26 Mar 2019	Tizanidine Hydrochloride Capsule	Cadila Pharma	Zanaflex (Covis)	Five
26 Mar 2019	Cephalexin Oral Suspension	Alkem	N/A	Four

 

Tentative ANDA Approvals 

Approval Date	Drug	Company
27 Mar 2019	Atazanavir;Cobicistat	Mylan

 

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