Search For "us fda"
Granules gets US drug regulator's nod for Amphetamine capsules
Updated : 3 years, 2 months ago IST
The product will be manufactured at Granules manufacturing facility in Chantilly, Virginia, and is expected to be launched shortly, according to a company statement shared with stock exchanges.
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Zydus gets US FDA final nod for Febuxostat tablets for treating high uric
Updated : 3 years, 2 months ago IST
According to the statement from Zydus, Febuxostat tablets are indicated to lower hyperuricemia (high uric acid in the blood) in patients with gout who have been treated with allopurinol that did not work well or cannot be treated with allopurinol.
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US regulator conducts inspection of Piramal's unit in US
Updated : 3 years, 2 months ago IST
The company said it was preparing a detailed response to the observations, which will be submitted to the US FDA within the stipulated timelines. The company said it remains committed to maintaining the highest standards of compliance and will work closely with the agency to address all the
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US FDA clears passage for pharmacies to dispense abortion pills
Updated : 3 years, 2 months ago IST
The US Food and Drug Administration has, for the first time cleared a passage for certified pharmacies to dispense abortion pills in the United States, Al Jazeera reported on Tuesday.
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Curadev Pharma announces the formation of its Clinical Advisory Group
Updated : 3 years, 2 months ago IST
Noida (Uttar Pradesh) [India], January 4 (ANI/PRNewswire): Curadev Pharma has created a Clinical Advisory Group (CAG) comprising eminent oncologists to provide guidance in the design and execution of immune-oncology clinical trials with CRD3874, its lead non-nucleoside, allosteric small mole
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US FDA Grants Breakthrough Designation for Blood Test to Help Diagnose Ina
Updated : 3 years, 2 months ago IST
Mumbai (Maharashtra) [India], January 3 (ANI/PRNewswire): Datar Cancer Genetics announced today that the US Food and Drug Administration (FDA) has granted 'Breakthrough Device Designation' for its 'TriNetra™-Glio', a blood test to help in the diagnosis of brain tumors. This is the thir
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Glenmark gets US drug regulator's nod for high BP medicine
Updated : 3 years, 3 months ago IST
Glenmark's Nicardipine Hydrochloride capsules of 20 mg and 30 mg will be distributed in the US by Glenmark Pharmaceuticals US, according to a statement from Glenmark.
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Balaxi Pharmaceuticals Limited conducts Groundbreaking Ceremony for its up
Updated : 3 years, 3 months ago IST
Hyderabad (Telangana) [India], December 13 (ANI/NewsVoir): NSE listed Balaxi Pharmaceuticals Limited, a leading IPR branded pharmaceutical company, performed the groundbreaking ceremony of its US-FDA, EU-GMP, WHO-Geneva Compliant Pharmaceutical Formulation Plant at Jadcherla Mandal, Telangan
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Sun Pharma, SPARC sign licence agreement for sale of seizure drug for inje
Updated : 3 years, 4 months ago IST
SPARC submitted a new drug application (NDA) to the US Food and Drug Administration (US FDA) for this product for the treatment of seizures in newborns in February 2022, according to Sun Pharma statement shared with stock exchanges.
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Dr YK Gupta gives clarification on speculation 'Ranitidine' being removed
Updated : 3 years, 6 months ago IST
New Delhi [India], September 15 (ANI): India on Tuesday dropped the antacid Ranitidine, which is sold as Zantac, from the National List of Essential Medicines 2022. It was earlier on the list of essential medicines.
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Zenara Pharma launches Paxzen tablet against mild to moderate COVID
Updated : 3 years, 6 months ago IST
Hyderabad (Telangana) [India], September 9 (ANI): Hyderabad-based Zenara Pharma, has announced that it has launched Nirmatrelvir and Ritonavir tablets in a combi pack as a treatment option for patients with mild to moderate symptoms of Covid-19.
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Shaji Baby John Chairman of Kings Infra Ventures Limited receiving the tec
Updated : 3 years, 7 months ago IST
Kochi (Kerala) [India], August 24 (ANI/NewsVoir): Kings Infra Ventures Ltd. has signed a pact with the Central Institute of Fisheries Technology (ICAR-CIFT) on Monday, August 22, 2022 for developing ready-to-eat and ready-to-serve fish products by adopting steam or water immersion technology
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