Last Updated on October 11, 2024 by The Health Master
Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Acetazolamide Tablets USP, 125 mg and 250 mg (USRLD: Diamox Tablets, 125 mg and 250 mg).
Acetazolamide is used to treat glaucoma, a condition in which increased pressure in the eye can lead to gradual loss of vision.
Acetazolamide decreases the pressure in the eye.
Acetazolamide is also used to reduce the severity and duration of symptoms (upset stomach, headache, shortness of breath, dizziness, drowsiness, and fatigue) of altitude (mountain) sickness.
The drug is used with other medicines to reduce oedema (excess fluid retention) and to help control seizures in certain types of epilepsy.
The product will be manufactured at the group’s formulation manufacturing facility in Baddi, Himachal Pradesh (India).
Acetazolamide Tablets USP, 125 mg and 250 mg had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022).
The group now has 358 approvals and has so far filed over 440 ANDA approvals since the commencement of the filing process in FY 2003-04.
USFDA gives approval for Carbidopa and Levodopa Tablets USP
USFDA gives approves for Tenofovir Alafenamide Tablets
USFDA gives approval for Brimonidine Tartrate Ophthalmic Solution, 0.15%
USFDA gives ANDA approval for Gabapentin tablets
USFDA gives tentative approval for Valbenazine capsules
USFDA gives approval for Obeticholic acid tablets
Medical Device alert: USFDA identifies recall of this Respiratory Devices as most serios
USFDA withdraws approval for this birth prevention drug
Cap on prices of Coronary Stents raised
Investigation initiated on alleged dumped import of Sodium Cyanide
CDSCO Calls for Information on 16 Fixed Dose Combinations
Drug alert: 59 out of 1251 samples declared as NSQ in February 2023
Calibration of Laboratory Instruments
Drug recall: 50,000 contaminated eye drops recalled
Glutathione: Lets talk about its dose and health benefits
Difference: Disintegration and Dissolution test in pharma industry
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
