NEWS 28 JAN 2019

NEWS FROM USA

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
23 Jan 2019	Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride Solution	Torrent	Rezira (Cypress)	Two (Mayne, Paddock)
23 Jan 2019	Ticagrelor Tablets	Amneal	Brilinta (Astrazeneca)	Two (Hisun Pharm, Watson )
23 Jan 2019	Ticagrelor Tablets	Hisun Pharm Hangzhou	Brilinta (Astrazeneca)	Two (Amneal, Watson )
23 Jan 2019	Clobetasol Propionate Ointment	Teligent	N/A	Ten
24 Jan 2019	Dorzolamide Hydrochloride Ophthalmic Drops	FDC Ltd	Trusopt (Merck)	Five
24 Jan 2019	Buprenorphine Hydrochloride; Naloxone Hydrochloride Sublingual	Alvogen Pine	Suboxone (Indivior)	Two (Dr Reddys, Mylan)
28 Jan 2019	Medroxyprogesterone Injectable	Cipla	Depo-Provera (Pfizer)	Five

 

Tentative ANDA Approvals 

Approval Date	Drug	Company
22 Jan 2019	Topiramate XR capsules	Glenmark

 

 

 

USFDA Inspections 

USDFA concludes audit at Indoco’s Goa Plant I

U.S. FDA completes inspection of Lupin’s Pithampur Unit-2 (Indore) facility

 

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