NEWS 24 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
Levothyroxine tablets	Lupin	Synthroid (Abbvie)	$2.5 Bn	Link

 

ANTICIPATED GENERIC LAUNCHES IN THE UPCOMING WEEK

DRUG	ANDA filers holding Tentative Approvals	Corresponding RLD	Reason
Tadalafil tablets	More than 10 (Cipla, Lupin, Sun, Alembic, Aurobindo and others)	Cialis (Lilly)	Expiry of Teva’s PC exclusivity on 26 Mar. 2019

 

ANDA Approvals

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
20 Mar 2019	Azelastine Ophthalmic solution	Alembic Pharma	Optivar (Mylan)	Four

 

Tentative ANDA Approvals 

Approval Date	Drug	Company
22 Mar 2019	Bimatoprost	Hi-Tech Pharma

 

USFDA Inspections

Alkem (St. Louis facility): Alkem provided update on USFDA inspection at St.Louis facility

Jubilant lifesciences (API facility-Mysore): Jubilant lifesciences provided update on USFDA inspection at Myore API facility

NEWS FROM EUROPE

 

Amlodipine/Valsartan(Stada): Stada introduces generic Amlodipine/Valsartan in EU following success in patent dispute at EPO.

 

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