NEWS 01 OCT 2018

NEWS FROM USA

NDA Approvals        

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
28 Sep 2018	Amikacin inhalation liposomal suspension	Insmed	Arikayce	Label

 

ANDA Approvals

           

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
27 Sep 2018	Ranitidine capsules	Ajanta Pharma	N/A	Three
28 Sep 2018	Minocycline extended release tablets	Aurobindo pharma	Solodyn (Medicis)	Six
1 Oct. 2018	Desoximetasone Cream	Zydus	Topicort 0.25% (Taro)	Six

*For more details on ANDA approvals click on the Drug Product Name 

 

NEW GENERICS LAUNCHES IN US

 

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Imatinib tablets	Dr. Reddy’s	Gleevec (Novartis)	$ 868 Mn	Link

 

OTHER NEWS FROM US

Kyprolis (Carfilzomib): Approval of Once weekly dosing option in combination with dexamethasone for Relapsed or Refractory Multiple Myeloma

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