Health Regulator News

Industry

USFDA recommends approval of Biocon’s breast cancer biosimilar

Mylan and Biocon said the USFDA 's advisory committee had recommended approval of their biosimilar trastuzumab for treatment of breast cancer

2 min read14 Jul 2017
Industry

Lupin gets USFDA nod to market anti-fungal capsules

Lupin has got a nod from US health regulator USFDA to market its Flucytosine capsules used for treatment of fungal infections

1 min read10 Jul 2017
Companies

Lupin gets USFDA nod for painkiller

Drug firm Lupin receives final approval from US health regulator USFDA for its tablets used in case of severe pain

1 min read14 Jun 2017
Companies

Sun Pharma receives USFDA nod for anti-cholesterol drug

Sun Pharma's generic version of ezetimibe tabletsused to reduce high cholesterol levelsreceive USFDA nod

1 min read13 Jun 2017
Companies

Zydus Cadila gets USFDA nod for generic epilepsy drug

USFDA gives green signal to Zydus Cadila's Felbamate tablets that are used to treat seizures in people with epilepsy

1 min read31 May 2017
Industry

USFDA accepts application for psoriasis drug: Sun Pharma

Sun Pharmaceutical says USFDA has accepted biologics licence application for tildrakizumab drug for the treatment of psoriasis

1 min read24 May 2017
Industry

Biocon says it has responded to all USFDA observations

Biocon said the company has already responded to USFDA on all observations of the recent audit within stipulated timelines

1 min read10 May 2017
Companies

Jubilant Life gets USFDA nod for hypertension drug

Jubilant Life's product is the generic version of Benicar of Daiichi Sankyo, which is used for the treatment of hypertension

1 min read25 Apr 2017
Companies

USFDA issues warning letter to Unimark Remedies

The USFDA says inspectors found significant deviations from standard manufacturing practices at Unimark Remedies' plants in Ahmedabad

1 min read24 Aug 2016
Industry

USFDA bans import of drugs from Wockhardt’s Ankleshwar plant

US health regulator has banned import of drugs produced at Wockhardt's Ankleshwar plant for non-compliance of manufacturing norms

1 min read5 Aug 2016
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