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Results For "New-Drug-Application"

372 News Found

Alembic receives USFDA tentative approval for hypertension drug
Drug Approval | March 14, 2022

Alembic receives USFDA tentative approval for hypertension drug

Macitentan tablets, 10 mg have an estimated market size of US $ 797 million for twelve months ending Dec 2021 according to IQVIA


USFDA approves Lupin’s Vigabatrin oral solution
Drug Approval | March 11, 2022

USFDA approves Lupin’s Vigabatrin oral solution

The product will be manufactured at Lupin’s facility in Goa, India


Aleor Dermaceuticals receives USFDA approval for Nystatin and Triamcinolone Acetonide ointment
Drug Approval | March 08, 2022

Aleor Dermaceuticals receives USFDA approval for Nystatin and Triamcinolone Acetonide ointment

Nystatin and Triamcinolone Acetonide ointment is indicated for the treatment of cutaneous candidiasis


Zydus’ OxemiaTM receives approval from DCGI to treat Anaemia associated with Chronic Kidney Disease
Drug Approval | March 07, 2022

Zydus’ OxemiaTM receives approval from DCGI to treat Anaemia associated with Chronic Kidney Disease

OxemiaTM (Desidustat) is an oral tablet formulation that is the first-in-India alternative to injectable erythropoietin-stimulating agents (ESAs)


USFDA refuses to grant EUA to Covaxin for padeatric use
News | March 04, 2022

USFDA refuses to grant EUA to Covaxin for padeatric use

Covaxin is not approved in the USA for any age group


Lupin receives USFDA approval for topical solution
Drug Approval | March 03, 2022

Lupin receives USFDA approval for topical solution

The product will be manufactured at Lupin’s facility in Pithampur, India


USFDA issues new clinical trial guidelines for cancer treatments
News | March 02, 2022

USFDA issues new clinical trial guidelines for cancer treatments

USFDA's industry recommendations and cancer Moonshot aim to improve lives of patients and their families


USFDA approves first generic version of Apokyn cartridges
Drug Approval | March 02, 2022

USFDA approves first generic version of Apokyn cartridges

TruPharma has commenced commercial marketing of Sage's approved generic cartridge product


China’s NMPA accepts supplemental NDA for Carteyva
Drug Approval | February 28, 2022

China’s NMPA accepts supplemental NDA for Carteyva

The sNDA was supported by the clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva in adult patients with relapsed or refractory B cell non-hodgkin lymphoma in China


USFDA lifts clinical hold on submission of Covaxin
News | February 20, 2022

USFDA lifts clinical hold on submission of Covaxin

Covaxin is a whole-virion inactivated Covid-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades