Zydus Lifesciences gains on getting final nod from USFDA for Brivaracetam Tablets

Zydus Lifesciences is currently trading at Rs. 423.00, up by 3.00 points or 0.71% from its previous closing of Rs. 420.00 on the BSE.

Zydus Lifesciences
Zydus Lifesciences

The scrip opened at Rs. 419.15 and has touched a high and low of Rs. 424.30 and Rs. 419.15 respectively. So far 36044 shares were traded on the counter.

The BSE group ‘A’ stock of face value Rs. 1 has touched a 52 week high of Rs. 566.65 on 05-Oct-2021 and a 52 week low of Rs. 319.40 on 11-May-2022.

Last one week high and low of the scrip stood at Rs. 424.35 and Rs. 368.80 respectively. The current market cap of the company is Rs. 42512.57 crore.

The promoters holding in the company stood at 74.88%, while Institutions and Non-Institutions held 14.88% and 10.24% respectively.

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Brivaracetam Tablets USP 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg. (USRLD: Briviact).

Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Brivaracetam Tablets USP 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg.

It is therefore eligible for 180 days of shared generic drug exclusivity for Brivaracetam Tablets USP 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg.

Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.

Brivaracetam Tablets USP 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg had annual sales of USD 412 mn in the United States according to IQVIA data (IQVIA MAT August 2022).

The group now has 326 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.

Download App to read Latest News Today

Leave a Comment