NEWS 01 JAN 2019

NEWS FROM USA

505 (b) 2s in pipeline

Risperidone Extended Release Microspheres for Injection (Luye Pharma): Luye Pharma announced that it has entered the final stage of NDA submissions for the Risperidone ER Microspheres for Injection in the treatment of Schizophrenia or Schizoaffective Disorder.

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
28 Dec 2018	Exemestane Tablets	Amneal	Aromasin (Pharmacia)	Six
28 Dec 2018	Irinotecan Hydrochloride Injection	Shilpa	Camptosar (Pfizer)	Ninteen
28 Dec 2018	Hydroxyprogesterone Caproate Solution	Slayback	Makena (Amag)	This product was mentioned in FDA’s off patent off exclusivity product with no generic list
28 Dec 2018	Verapamil Hydrochloride Solution	Micro	N/A	Seven
31 Dec 2018	Clozabam oral suspension	Lupin	Onfi (Lundbeck)	Six

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

 

 

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