Zydus Life reaches a 52-week peak following the USFDA's approval of Lacosamide tablets

18 Dec 2023 , 12:38 PM

In early trading on December 18, Zydus Lifesciences’ stock price increased by 3% to reach a 52-week high of Rs 672.35. This came after the company received final approval from the US Food and Drug Administration (USFDA) to produce and sell Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg.

The recommended medication for partial-onset seizures is lacosamide. It is also used to treat primary generalised tonic-clonic seizures in combination with other medications.

The product will be produced at the Moraiya, Ahmedabad (India) formulation manufacturing facility of the group.

Since the filing procedure began in FY 2003–04, the group has filed over 448 ANDAs and currently has 384 approvals.

In a further development, the business declared that the USFDA has given it authorization to start a Phase II clinical trial of the NLRP3 inhibitor ‘ZYIL1’ in Parkinson’s disease patients.

The US health agency gave the business permission to market Darunavir Tablets, a generic antiviral drug used to treat HIV-1 infection, on December 15.

On December 11, the business revealed that Zydus Worldwide DMCC, its wholly-owned subsidiary, had signed a licence agreement with Daewoong Pharmaceutical Co Ltd. of South Korea to jointly develop and market a generic version of Leuprolide Acetate for depot suspension, which is used to treat endometriosis, uterine leiomyomata, and advanced prostatic cancer (fibroids).

The USFDA gave the company final permission on December 6 to begin producing and selling Methylene Blue Injection, which is used to treat acquired methemoglobinemia in adults and children. The injection comes in two dosage forms: 10 mg/2 ml and 50 mg/5 ml.

Ivabradine Tablets, 5 mg and 7.5 mg, are intended to lower the risk of hospitalisation for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with a reduced left ventricular ejection fraction. The company got final approval from the USFDA for these tablets on December 1.

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