NEWS 11 OCT 2018

NEWS FROM USA

ANDA Approvals 

 

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
09 Oct 2018	Dofetilide capsules	Par  Pharma	Tikosyn (Pfizer)	Four
09 Oct 2018	Dofetilide capsules	Sun Pharma	Tikosyn (Pfizer)	Four

 

OTHER NEWS FROM USA

USFDA publishes updated list of USDMF (Link)

Sun Pharma sued Teva for paragraph iv filing of generic Yonsa (Abiraterone). It is worth to note that Sun received USFDA approval for Yonsa on 22 May 2018 and Teva submitted ANDA for Yonsa on 23 July 2018 (i.e. within 62 days).

 

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