NEWS 31 OCT 2018

NEWS FROM USA

NDA Approvals        

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
19 Oct 2018	Meloxicam Disintegrating Tablets	Tersera	Qmiiz ODT	Label
28 Oct 2018	Estradiol;Progesterone Capsule	Therapeuticsmd	Bijuva	Label

 

 

ANDA Approvals 

 

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
26 Oct 2018	Teriflunomide Tablets	Aurobindo	Aubagio (Sanofi )	Three
26 Oct 2018	Felodipine ER Tablets	Yiling Pharm	N/A	Ten
26 Oct 2018	Progesterone Capsule	Eugia	Prometrium (Virtus)	Six
26 Oct 2018	Clobetasol Propionate Lotion	Hi-Tech	Clobex (Galderma )	Four
26 Oct 2018	Albuterol Sulfate Tablets	Novitium	N/A	Four
26 Oct 2018	Quetiapine Fumarate ER Tablets	Amneal	Seroquel XR (Astrazeneca)	Ten
26 Oct 2018	Methocarbamol Solution	Gland Pharma	Robaxin (West-Ward)	Nine
26 Oct 2018	Liothyronine Sodium Tablets	Teva	Cytomel (King)	Four
29 Oct 2018	Midodrine Hydrochloride Tablets	Par Pharm	N/A	Five
30 Oct 2018	Glycopyrrolate Tablets	Aurolife	N/A	Nine
30 Oct 2018	Fluocinolone Acetonide Topical Oil (Scalp Oil)	Glenmark	Derma-Smoothe/FS (Hill Dermaceuticals)	Ten

                                               

Tentative ANDA Approvals                       

Approval Date	Drug	Company
26 Oct 2018	Methylergonovine Maleate	Teva

 

NEW GENERICS LAUNCHES IN US

 

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Atomoxetine Capsule	DR Reddy	Strattera (Eli Lilly)	$ 304 Million	Link

 

USFDA Inspection

 

Dr Reddy's gets 8 observations from USFDA for Duvvada plant

                                               

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