Zydus Lifesciences US arm bags USFDA nod for Brivaracetam Tablets to treat partial-onset seizures

Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.

Published On 2022-10-06 05:47 GMT   |   Update On 2022-12-21 09:13 GMT

Ahmedabad: Zydus Lifesciences Limited's (formerly known as Cadila Healthcare Limited) U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. 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...

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Ahmedabad: Zydus Lifesciences Limited's (formerly known as Cadila Healthcare Limited) U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. 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.

Read also: Zydus Lifesciences US arm bags USFDA nod for generic version of Mirabegron ER tablets

Zydus group is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil. Zydus' global business has a strong presence in the regulated markets of the US, Europe (France and Spain) and in the high profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide

Read also: Zydus Lifesciences bags USFDA nod for Sildenafil for Oral Suspension

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