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Tag: usfda

You Searched For "usfda"
Lupin gets USFDA approval for Meloxicam to treat osteoarthritis pain

Lupin gets USFDA approval for Meloxicam to treat osteoarthritis pain

Ruchika Sharma3 Jun 2020 10:45 AM IST
Meloxicam Capsules, 5 mg and 10 mg, are indicated for the management of osteoarthritis (OA) pain
Strides Pharma gets USFDA nod for generic version of triamcinolone acetonide to treat skin conditions

Strides Pharma gets USFDA nod for generic version of triamcinolone acetonide to treat skin conditions

Farhat Nasim2 Jun 2020 3:02 PM IST
The approval is granted to the company's step-down wholly-owned subsidiary, Strides Pharma Global, Singapore, by USFDA for triamcinolone acetonide...
Roche Itovebi recommended by CHMP for EU approval for PIK3CA-mutated, ER-positive, HER2-negative, advanced breast cancer

Roche gets USFDA nod to Tecentriq-Avastin combination to treat liver cancer

Ruchika Sharma1 Jun 2020 1:48 PM IST
Zurich: Swiss drugmaker Roche said on Friday that the U.S. Food and Drug Administration (FDA) approved its immunotherapy Tecentriq in combination with...
5 firms told to recall Metformin for high levels of probable carcinogen

5 firms told to recall Metformin for high levels of probable carcinogen

Ruchika Sharma31 May 2020 12:30 PM IST
The U.S. Food and Drug Administration (FDA) said on Thursday it has recommended five pharmaceutical firms to voluntarily recall their diabetes drug...
AIIMS Rishikesh Partners With Stasis to Launch Remote Monitored COVID-19 Isolation Wards Using Made-in-India Technology

AIIMS Rishikesh Partners With Stasis to Launch Remote Monitored COVID-19 Isolation Wards Using Made-in-India Technology

Medical Dialogues Bureau31 May 2020 11:24 AM IST
BENGALURU - All India Institute of Medical Sciences (AIIMS), Rishikesh has teamed up with Stasis, a Bangalore-based start-up, to implement a remote...
Cadila Healthcare receives EIR from USFDA for Baddi facility

Cadila Healthcare receives EIR from USFDA for Baddi facility

Ruchika Sharma30 May 2020 11:00 AM IST
The EIR report stated that the classification of the facility is no action indicated (NAI), it added
FDA approves drug for heavy menstrual bleeding due to fibroids

FDA approves drug for heavy menstrual bleeding due to fibroids

Dr. Kamal Kant Kohli30 May 2020 7:43 AM IST
The U.S. Food and Drug Administration has approved Oriahnn capsules for the management of heavy menstrual bleeding associated with uterine...
Dr Reddys Labs gets USFDA EIR for IPDO facility

Dr Reddy's Labs gets USFDA EIR for IPDO facility

Ruchika Sharma29 May 2020 10:53 AM IST
New Delhi: Dr. Reddy''s Laboratories on Thursday said the US health regulator has closed inspection of its Telangana-based facility.The company has...
Glenmark Pharma gets USFDA nod for  Chlorzoxazone Tablets

Glenmark Pharma gets USFDA nod for Chlorzoxazone Tablets

Ruchika Sharma27 May 2020 2:56 PM IST
This marks Glenmark’s first ANDA approval out of their new North American manufacturing facility based in Monroe, North Carolina
AstraZeneca, Daiichi Sankyo get Orphan Drug Designation for gastric cancer drug Enhertu

AstraZeneca, Daiichi Sankyo get Orphan Drug Designation for gastric cancer drug Enhertu

Ruchika Sharma25 May 2020 11:56 AM IST
US: Daiichi Sankyo Company Limited and AstraZeneca's Enhertu (trastuzumab deruxtecan) has been granted Orphan Drug Designation (ODD) in the US for the...
Sunovion Pharmaceuticals gets USFDA nod for KYNMOBI for Parkinsons disease off episodes

Sunovion Pharmaceuticals gets USFDA nod for KYNMOBI for Parkinson's disease off episodes

Ruchika Sharma24 May 2020 10:00 AM IST
KYNMOBI dissolves under the tongue to help people with PD improve their OFF symptoms as needed
Gilead holds talks with Health Ministry, DCGI  officials to bring Remdesivir to India

Gilead holds talks with Health Ministry, DCGI officials to bring Remdesivir to India

Ruchika Sharma23 May 2020 12:00 PM IST
The medicine has been issued an Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA) to treat hospitalised...
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