Zydus Cadila gets USFDA nod for schizophrenia treatment drug

PTIUpdated: Thursday, September 09, 2021, 02:27 PM IST
article-image
Zydus Cadila noted that it will manufacture the schizophrenia treatment drug at its manufacturing facility at the SEZ, Ahmedabad/ Representational image |

Drug firm Zydus Cadila on Thursday said it has received approval from the US health regulator to market Brexpiprazole tablets, used for the treatment of schizophrenia, in the American market.

The company has received tentative approval from the US Food and Drug Administration (USFDA) to market Brexpiprazole tablets in the strength of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, the drug firm said in a statement.

Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) and for treatment of schizophrenia.

Zydus Cadila noted that it would manufacture the drug at its manufacturing facility at the SEZ, Ahmedabad.

The Ahmedabad-based group now has 321 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04.

(To receive our E-paper on whatsapp daily, please click here. To receive it on Telegram, please click here. We permit sharing of the paper's PDF on WhatsApp and other social media platforms.)

RECENT STORIES

SIP vs lump sum investment? What should you consider?

SIP vs lump sum investment? What should you consider?

BPCL to bring in oil from Brazil to reduce reliance on any particular region

BPCL to bring in oil from Brazil to reduce reliance on any particular region

After Rupee hits record low, Fin Min says it has held up better than other currencies

After Rupee hits record low, Fin Min says it has held up better than other currencies

The government seeks public feedback on India’s new telecom bill to bring WhatsApp and Zoom under...

The government seeks public feedback on India’s new telecom bill to bring WhatsApp and Zoom under...

Bengaluru-based bakery emerges as giant killer by defeating Amazon in 4-year-long court battle

Bengaluru-based bakery emerges as giant killer by defeating Amazon in 4-year-long court battle