Granules India gets USFDA nod for Vigabatrin oral solution
Granules India has today informed the bourses that the company has received US Food & Drug Administration (USFDA) approval for abbreviated new drug application (ANDA), Vigabatrin for oral solution USP, 500 mg. It was filed by Granules Pharmaceuticals, Inc (GPI), a wholly-owned foreign subsidiary of Granules India Limited.
Vigabatrin for oral solution is indicated as an adjunctive therapy for adults and pediatric patients, two years of age and older with refractory complex partial seizures, who have inadequately responded to several alternative treatments.
With USFDA approval, this product becomes the company’s first speciality product approved in oral solution dosage.
As per IQVIA Health’s data, Vigabatrin for oral solution had US sales of approximately $255 million MAT for the most-recent twelve months, ending February 2020.
Recently in this month, the company has received two ANDA approvals for Trospium Chloride extended-release capsules, 60 mg as well as Butalbital, Acetaminophen and Caffeine capsules USP, 50 mg/300 mg/40 mg.
Granules India now has a total of 27 ANDA approvals from USFDA (25 final approvals and two tentative approvals).
In today’s trading session, the stock of Granules India opened at Rs 172.55 and jumped 5 per cent and made an intraday high of Rs 175.40 on BSE.