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Results For "USFDA"

1205 News Found

Dr. Reddy's announces the first-to-market, OTC launch of Allegra-D in the US market
Drug Approval | July 24, 2022

Dr. Reddy's announces the first-to-market, OTC launch of Allegra-D in the US market

Allegra-D had U.S. retail sales of approximately $45 million as of May 2022 according to IRI.


Dr. Reddy's Labs launches Fesoterodine Fumarate tablets in US
Drug Approval | July 10, 2022

Dr. Reddy's Labs launches Fesoterodine Fumarate tablets in US

Dr. Reddy's Fesoterodine Fumarate Extended-Release Tablets are available in 4 mg and 8 mg Tablets, each in bottle count sizes of 30.


Dr. Reddy's Laboratories updates on PAI of formulations facility
Drug Approval | July 08, 2022

Dr. Reddy's Laboratories updates on PAI of formulations facility

The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.


OliX Pharmaceuticals submits application to U.S. FDA to evaluate safety and tolerability of OLX10212
Drug Approval | July 04, 2022

OliX Pharmaceuticals submits application to U.S. FDA to evaluate safety and tolerability of OLX10212

The objective of this Phase 1 study is to determine the safety and tolerability of OLX10212 in patients with advanced AMD at multiple sites in the US.


Dr. Reddy's Lab launches sorafenib tablets in US
News | June 15, 2022

Dr. Reddy's Lab launches sorafenib tablets in US

Dr. Reddy's Sorafenib Tablets, USP, are available in 200 mg tablets in bottle count sizes of 120.


Eli Lilly gets FDA approval for alopecia drug
Drug Approval | June 15, 2022

Eli Lilly gets FDA approval for alopecia drug

Alopecia areata usually presents as a few small bald patches in the head


Sumitomo Pharma Oncology receives orphan drug designation for the treatment of myelofibrosis
Drug Approval | June 09, 2022

Sumitomo Pharma Oncology receives orphan drug designation for the treatment of myelofibrosis

TP-3654 is currently being evaluated in a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with intermediate or high-risk primary or secondary myelofibrosis.


Lupin receives tentative approval from FDA for Ivacaftor tablets
Drug Approval | June 08, 2022

Lupin receives tentative approval from FDA for Ivacaftor tablets

Ivacaftor Tablets had estimated annual sales of USD 109 million in the US.


Bempedoic acid market in India will get crowded soon:  GlobalData
News | May 27, 2022

Bempedoic acid market in India will get crowded soon: GlobalData

Bempedoic acid helps lower cardiovascular risk in high or very high-risk atherosclerotic cardiovascular disease (ASCVD) patients as an add-on therapy to maximally tolerated statin and/or ezetimibe


Dr. Reddy's and Senores Pharmaceuticals launches Ketorolac Tromethamine tablets in the U.S. market
News | May 25, 2022

Dr. Reddy's and Senores Pharmaceuticals launches Ketorolac Tromethamine tablets in the U.S. market

The Toradol tablets, 10 mg brand and generic had U.S. sales of approximately US $ 16.8 million MAT for the most recent twelve months ending in March 2022 according to IQVIA