NEWS 15 NOV 2018

NEWS FROM USA

NDA Approvals        

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
07 Nov 2018	Epinephrine Aerosol	Armstrong	Primatene Mist	Label
09 Nov 2018	Revefenacin Solution	Theravance	Yupelri	Label

 

ANDA Approvals 

 

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
07 Nov 2018	Norepinephrine Bitartrate Injection	Hikma	Levophed (Hospira)	Five
07 Nov 2018	Tetracycline Hydrochloride Capsule	Breckenridge	Achromycin V (Heritage)	Three
07 Nov 2018	Acetaminophen; Hydrocodone Bitartrate Tablets	Ascent	None	Seventeen
08 Nov 2018	Bimatoprost Ophthalmic Drops	Hi Tech	N/A	Three
08 Nov 2018	Ganciclovir Sodium Injection	Hainan Poly	Cytovene (Roche)	Five
08 Nov 2018	Nystatin; Triamcinolone Acetonide Ointment	Zydus	N/A	Eleven
08 Nov 2018	Acetaminophen; Hydrocodone Bitartrate Tablets	Alvogen Pine	N/A	Thirteen
09 Nov 2018	Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate Tablets	Teva	Atripla (Gilead)	One (Aurobindo)
09 Nov 2018	Anastrozole Tablets	Beijing	Arimidex (ANI Pharma)	Eleven
09 Nov 2018	Valganciclovir Hydrochloride Tablets	Cipla	Valcyte (Hoffmann)	Five
09 Nov 2018	Doxycycline Hyclate Tablets	Emcure	N/A	Eight
09 Nov 2018	Benzonatate Capsule	Aiping	Tessalon (Pfizer)	Nine
09 Nov 2018	Decitabine Iv Injection	Lupin	Dacogen (Otsuka)	Seven
09 Nov 2018	Budesonide Inhalation	Lupin	Pulmicort Respules (Astrazeneca)	Five
13 Nov 2018	Arsenic Trioxide Injection	Amring	Trisenox	Two (Fresenius, Zydus)
13 Nov 2018	Arsenic Trioxide Injection	Zydus	Trisenox	Two (Fresenius, Amring)
13 Nov 2018	Atropine Sulfate; Diphenoxylate Hydrochloride Tablets	Bayshore	Lomotil (Gd Searle)	Five

 

                                     

Tentative NDA Approvals              

Approval Date	Drug	Company
06 Nov 2018	Halobetasol Propionate	Dow Pharm

 

 

 

Tentative ANDA Approvals

 

Approval Date	Drug	Company
06 Nov 2018	Ticagrelor	Prinston Pharma
09 Nov 2018	Mesalamine	Pharma Sourcing
09 Nov 2018	Ticagrelor	Alkem
09 Nov 2018	Solifenacin Succinate	Glenmark Pharms
09 Nov 2018	Dimethyl Fumarate	Shilpa Medicare
09 Nov 2018	Bortezomib	Qilu Pharma

 

 

 

NEW GENERICS LAUNCHES IN US

 

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Atovaquone Oral Suspension	Lupin	Mepron (GSK)	$119 Million	Link

 

USFDA Inspection

Biocon's Generic Formulations Facility in Bengaluru completes U.S. FDA Inspection with Zero observation

Lupin's Nagpur Facility Receives EIR From US FDA

 

                                               

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