NEWS 26 NOV 2018

NEWS FROM USA

NDA Approvals        

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
21 Nov 2018	Glasdegib Tablets	Pfizer	Daurismo	Label
21 Nov 2018	Indocyanine green IV	Novadaq technology	Spy agent green	Label

 

Supplement NDA approvals

Venetoclax indication expansion: AbbVie Receives US FDA Accelerated Approval for VENCLEXTA® (venetoclax) for Treatment of Newly-Diagnosed Acute Myeloid Leukemia Patients Ineligible for Intensive Chemotherapy

505(b)2  products in pipeline

Rizatriptan oral films (IntelGenx): IntelGenx announces fda’s acceptance of resubmission of new drug application for Rizaport (PDUFA date: 1 Apr. 2019)

Paclitaxel Injection Concentrate for Suspension (Sun Pharma, 505 (b) 2 of Abraxane): SPARC Announces Top-line Results of Pivotal Bioequivalence Study for Paclitaxel Injection Concentrate for Suspension

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Abiraterone tablets	Apotex	Zytiga (Janssen)	N/A	Link

 

ANDA Approvals 

 

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
19 Nov 2018	Heparin Sodium Injection	Sterinova	Heparin Sodium (Pfizer)	N/A
20 Nov 2018	Dyclonine Hydrochloride Solution	Novocol	Dyclone (Astrazeneca)	None
20 Nov 2018	Buprenorphine  ER Transdermal	Watson	Butrans (Purdue)	None
20 Nov 2018	Atorvastatin Calcium Tablets	Zydus	Lipitor (Pfizer)	Eleven
20 Nov 2018	Levocetirizine Dihydrochloride Tablets	Micro	Xyzal Allergy 24hr (Sanofi)	One (Dr Reddy)
21 Nov 2018	Atovaquone Oral Suspension	Glenmark	Mepron (GSK)	Four
21 Nov 2018	Calcitriol solution	Invatech	Rocaltrol (Validus)	One
21 Nov 2018	Potassium chloride oral solution	Novel (Lupin)	Potassium chloride (Pharma Res software)	None
21 Nov 2018	Methylphenidate ER tablets	Granules	None	Four
21 Nov 2018	Fluoxetine tablets	Appco pharma	Fluoxetine (Alvogen)	Three
21 Nov 2018	Clomipramine Capsules	Lupin	Anafranil (Specgx)	Six
23 Nov 2018	Roflumilast tablets	Hetero	Daliresp (Astra Zeneca)	Three

 

Tentative ANDA Approvals

 

Approval Date	Drug	Company
20 Nov 2018	Halobetasol Propionate	Perrigo
21 Nov 2018	Dimethyl Fumarate	Zydus
23 Nov 2018	Clobetasol emulsion foam	Glenmark

 

 

USFDA inspections

Indoco’s Goa Plant II & III clears USFDA inspection

 

 

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