NEWS 20 NOV 2018

NEWS FROM USA

NDA Approvals        

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
16 Nov 2018	Rifamycin Dr Tablets	Cosmo Technologies	Aemcolo	Label
20 Nov 2018	Emapalumab-Lzsg Injection	Novimmune	Gamifant	Link

 

ANDA Approvals 

 

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
15 Nov 2018	Propofol Injection	Dr Reddys	Diprivan (Fresenius)	Three
15 Nov 2018	Ketorolac Tromethamine Ophthalmic Drops	Aurobindo Pharma	Acular  Ls (Allergan)	Three
15 Nov 2018	Abacavir Sulfate; Lamivudine Tablets	Zydus Pharms	Epzicom (Viiv Hlthcare)	Five
15 Nov 2018	Arsenic Trioxide Injection	Ingenus Pharms	Trisenox (Teva)	Four
15 Nov 2018	Teriflunomide Tablets	Glenmark Pharms	Aubagio (Sanofi)	Five
15 Nov 2018	Arsenic Trioxide Injection	Nexus	Trisenox (Teva)	Four
16 Nov 2018	Naproxen Sodium Tablets	Novelgenix Theraps	Aleve (Bayer)	Nine
16 Nov 2018	Vardenafil Hydrochloride Tablets	Alembic Pharms	Staxyn (Bayer Hlthcare)	Four
16 Nov 2018	Acetaminophen; Hydrocodone Bitartrate Tablets	Elite Labs	N/A	Four
16 Nov 2018	Cetirizine Hydrochloride; Pseudoephedrine Hydrochloride ER Tablets	Perrigo	Zyrtec-D 12 Hour (J And J Consumer)	Three
16 Nov 2018	Succinylcholine Chloride Injection	Amneal Pharms	Anectine (Sandoz)	Three
19 Nov 2018	Azelaic Acid Gel	Glenmark	Finacea (Leo Pharma)	Three
19 Nov 2018	Azelaic Acid	Actavis	Finacea (Leo Pharma)	Three
19 Nov 2018	Azelaic Acid	Tolmar	Finacea (Leo Pharma)	Three

 

USFDA Inspection

USFDA completes Dr Reddy’s Formulations Srikakulum Plant (SEZ) Unit II, Andhra Pradesh with zero observations.

 

NEW GENERICS LAUNCHES IN US

 

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Triazolam Tablets	Hikma	Halcion (Pifzer)	$27 Million	Link

                                                                                                                                                                                                                                                                                     

 

                                                                            

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