NEWS 21 MAR 2019

NEWS FROM USA

NDA Approvals                    

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
18 Mar 2019	Ceritinib Tablets*	Novartis	Zykadia	Link
19 Mar 2019	Brexanolone Injection	Sage Therapeutics	Zulresso	Link
20 Mar 2019	Solriamfetol Tablets	Jazz Pharma	Sunosi	Link

*Capsule dosage form of Ceritinib is approved since 2014. There is no para IV filing reported for the capsule dosage form of Ceritinib as per the latest FDA Para IV list.

 

ANDA Approvals

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
19 Mar 2019	Fluocinonide Topical Solution	Teligent Pharma	Fluocinonide (Taro)	Four

 

Tentative ANDA Approvals 

Approval Date	Drug	Company
19 Mar 2019	Pregabalin	Dr Reddys

 

NEWS FROM EU

Abraxane (Paclitaxel) SPC: CJEU delivers landmark judgment on SPC (Supplementary protection certificate) application concerning a new formulation of an old active ingredient. As a result of this decision, generic filers may launch Abraxane generic on approval.

 

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