NEWS 24 AUG 2018

 

NEWS FROM USA

NDA Approvals        

DRUG	COMPANY	Brand Name	Press release if available
Loteprednol etabonate ophthalmic suspension	Kala Pharma	Inveltys	Link
Tretinoin topical lotion	Dow Pharma	Altreno

 

ANDA Approvals     

DRUG	COMPANY	Corresponding RLD	Press release if available
Ibuprofen tablets OTC	Aiping pharma	Motrin IB (J & J)
Aspirin/Dipyridamole ER capsules	Sun	Aggrenox (Boehringer)
Dexmedetomidine injection (4 mcg/ml) (First generic approval)	Baxter	Precedex (Hospira)
Cefepime lyo powder 100 gm in plastic container First approval for this strength	Samson	N/A
Clobetasol propionate ointment 0.05%	Amneal	N/A
Fluocinonide Cream 0.05%	Amneal	Fluocinonide (Taro)
Diphenydramine injection	Micro	N/A
Dexamethasone injection	Amneal	N/A
Emtricitabine and Tenofovir disoproxil fumarate tablets (First generic approval)	Amneal	Truvada (Gilead)
Neostigmine methylsulfate IV solution	Renaissance	Bloxiverz (Avadel)

 

Tentative Approvals           

DRUG	COMPANY	Corresponding RLD	Press release if available
Bortezomib injection	Mylan	Velcade (Millenium)

 

 

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