Last Updated on December 24, 2023 by The Health Master
Granules India announced that the US Food & Drug Administration (USFDA) has approved its Abbreviated New Drug Application (ANDA) for Gabapentin Tablets USP, 600 mg and 800 mg.
It is bioequivalent to the reference listed drug product (RLD), Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty LLC.
Gabapentin tablets are indicated for management of postherpetic neuralgia in adults; and as an adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalisation, in adults and pediatric patients three years and older with epilepsy.
Granules now have a total of 55 ANDA approvals from USFDA (53 final approvals and two tentative approvals).
The current annual US market for Gabapentin Tablets is approximately $145 million, according to MAT Jan 2023, IQVIA/IMS Health.
USFDA gives tentative approval for Valbenazine capsules
USFDA gives approval for Obeticholic acid tablets
USFDA gives approval for this Antifungal drug
USFDA grants accelerated approval for Skin cancer therapy
USFDA gives approval for Calcipotriene and Betamethasone foam
USFDA gives approval for Brexpiprazole tablets
NPPA fixed retail price of 25 formulations: March 2023
NPPA announces annual change of 12.12% in Wholesale Price Index
USFDA gives tentative approval for Valbenazine capsules
CDSCO gives marketing approval for this Diabetes drug in pre-filled pen
Remdesivir not a wonder drug, affects heart: Study
Drug recall: 55,000 bottles of Colchicine tablets due to this reason
Difference: Disintegration and Dissolution test in pharma industry
How to prepare SOPs in the Pharma Industry
Difference between branded and generic medicines
Understanding DQ, IQ, PQ, and OQ in the Pharma Industry
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
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:
