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Results For "NDA"

4009 News Found

Alkem denies claims of Pan-D, Clavam 625 batches being substandard quality
News | September 27, 2024

Alkem denies claims of Pan-D, Clavam 625 batches being substandard quality

The samples of both products mentioned in the CDSCO list are spurious and not manufactured by Alkem


AstraZeneca advances ambition to improve standards of care in multiple cancer types
News | September 04, 2024

AstraZeneca advances ambition to improve standards of care in multiple cancer types

Presidential Symposium for NIAGARA will highlight practice-changing impact of a perioperative Imfinzi-based regimen in bladder cancer


Indoco Remedies receives final ANDA approval from the USFDA for Lofexidine Tablets 0.18 mg
Drug Approval | August 21, 2024

Indoco Remedies receives final ANDA approval from the USFDA for Lofexidine Tablets 0.18 mg

This product will be manufactured by Indoco at its manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa in India


Ashland Rad-Sure indicators approved by AABB Standards-Compliant product program
News | August 21, 2024

Ashland Rad-Sure indicators approved by AABB Standards-Compliant product program

Rad-Sure blood irradiation indicators are FDA 510 (k) cleared medical devices that offer positive visual verification of irradiation at the minimum specified dose


Sequent Scientific receives WHO prequalification approval for Albendazole API
News | August 20, 2024

Sequent Scientific receives WHO prequalification approval for Albendazole API

This is in partnership with Mepro Pharmaceuticals which have successfully developed and commercialised the Albendazole Chewable formulation


Granules India receives ANDA approval for Glycopyrrolate Oral Solution
Drug Approval | August 20, 2024

Granules India receives ANDA approval for Glycopyrrolate Oral Solution

Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients


Granules India receives ANDA approval for Trazodone Tablets
Drug Approval | August 11, 2024

Granules India receives ANDA approval for Trazodone Tablets

Trazodone tablets are indicated for the treatment of major depressive disorder in adults


CCRUM organises webinar on quality standards for healthcare delivery system in Unani Medicine
News | August 08, 2024

CCRUM organises webinar on quality standards for healthcare delivery system in Unani Medicine

Nearly 200 participants from 50 Unani Academia and Council participated


Bayer submits NDA to USFDA for elinzanetant for the treatment of VMS associated with menopause
Drug Approval | August 01, 2024

Bayer submits NDA to USFDA for elinzanetant for the treatment of VMS associated with menopause

The New Drug Application (NDA) includes data from the Phase III studies OASIS 1, 2 and 3 - showing elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms over 12 weeks compared to placebo