NEWS 09 OCT 20118

NEWS FROM USA

ANDA Approvals

 

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
03 Oct 2018	Vancomycin Hydrochloride Injection	Hikma Pharms	None	Three

 

Tentative NDA Approvals           

Approval Date	Drug	Company
05 Oct 2018	Halobetasol Propionate (Final approval is expected in Nov 2018)	Dow Pharm

 

NEW GENERICS LAUNCHES IN US

 

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Clobetasol Propionate Ointment	Lupin	Temovate Ointment (Fougera Pharmaceuticals)	$ 93.4 Mn	Link

                                                                                                              

OTHER NEWS FROM USA

 

FDA published two new draft guidance for generic transdermal and topical delivery systems:

1)     Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs

2)    Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs

 

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