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Wednesday, July 11, 2018

NEWS 11 JULY 2018

 

NEWS FROM USA

DRUG

COMPANY

NEWS

Hydroxychloroquine Sulfate

Dr Reddy

Dr. Reddy's Laboratories announces the launch of Hydroxychloroquine Sulfate Tablets in the U.S. Market

Azithromycin

Aurobindo

Aurobindo Pharma receives USFDA Approval for Azithromycin Tablets

                                               

NDA Approvals

DRUG

COMPANY

Comment

VANCOMYCIN lyophilized powder

(250 mg, 750 mg, 1.25 gm and 1.5 gm)

 

Approval date: 10 July 2018

Mylan

Prescribing information

 

Previously approved strengths: 500 mg, 750 mg, 1 gm, 5 gm and 10 gm

 

Other ANDA Approvals      

DRUG

COMPANY

Corresponding RLD

Tobramycin

Dr Reddys 

Tobi (Novartis)

Alprazolam

Centaur Pharms 

Xanax (Pharmacia And Upjohn)

Clarithromycin

Sunshine 

N/A

Iloperidone

Alembic Pharma

Fanapt (Vanda Pharmaceuticals)

 

 

NEWS FROM INDIA

·         Boehringer Ingelheim India and Lupin expand collaboration for co-marketing of two oral anti-diabetic drugs

NEWS FROM EU & CANADA

·         EMA reviewing medicines containing valsartan from Zhejiang Huahai following detection of an impurity

 

·         Several drugs containing valsartan being recalled due to contamination with a potential carcinogen

 

 

*For browsing official press releases click on the respective news item.

 

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