NEWS 11 SEP 2018

 NEWS FROM USA

NDA Approvals        

Approval Date	Drug	Company	Brand Name	Press Release If Available
07 Sep 2018	Buprenorphine;Naloxone SL Film (505(b)2 Against Suboxone- New Strength)	Teva	Cassipa	Label

 

ANDA Approvals     

Approval Date	Drug	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
05 Sep 2018	Loperamide Hydrochloride; Simethicone Tablets	Perrigo	Imodium Multi-Symptom Relief	One (Sun)
06 Sep 2018	Oxybutynin Chloride Tablets	Tulex	N/A	Six
07 Sep 2018	Lamivudine; Zidovudine Tablets	Cipla	Combivir	Ten

 

Tentative ANDA Approvals           

Approval Date	Drug	Company
07 Sep 2018	Lurasidone Hydrochrloride Tablets	Torrent
07 Sep 2018	Sitagliptin	Zydus

           

OTHER NEWS FROM THE USA

 

U.S. Court of Appeals for the Federal Circuit Upholds District Court’s Decision to Invalidate AMPYRA (dalfampridine) Patents

 

NEWS FROM EUROPE

Glenmark secures marketing authorization in Germany for its generic version of Seretide Accuhaler

 

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