Zydus Lifesciences share price gained 3 percent to hit a 52-week high of Rs 672.35 in the early trade on December 18 after the company received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg.
Lacosamide is indicated to treat partial-onset seizures. It is also used with other medicines to treat primary generalized tonic-clonic seizures.
The product will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India).
The group now has 384 approvals and has so far filed over 448 ANDAs since the commencement of the filing process in FY 2003-04.
In another development, the company announced that it has received permission from USFDA, to initiate the Phase II clinical study of NLRP3 inhibitor “ZYIL1” in patients with Parkinson’s disease.
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Approval and Developments in December
On December 15, the company received approval from the US health regulator to market a generic antiviral medication, Darunavir Tablets, used in the treatment of HIV-1 infection.
On December 11, the company announced that its wholly-owned subsidiary, Zydus Worldwide DMCC, entered into a licensing pact with South Korea's Daewoong Pharmaceutical Co Ltd to co-develop and commercialise a generic version of Leuprolide Acetate for depot suspension used to treat advanced prostatic cancer, endometriosis and uterine leiomyomata (fibroids).
On December 6, the company received final approval from the USFDA for the manufacturing and marketing of Methylene Blue Injection, available in 10mg/2ml and 50mg/5ml variants, used for treating pediatric and adult patients with acquired methemoglobinemia.
Also, Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. executed an Assignment and Assumption Agreement with Cyprium Therapeutics, Inc., a Fortress Biotech, Inc. subsidiary company, under which Cyprium completed the transfer of its worldwide proprietary rights and USFDA documents about CUTX-101, the copper histidine product candidate for the treatment of Menkes disease, to Sentynl.
On December 1, the company received final approval from the USFDA for Ivabradine Tablets, 5 mg and 7.5 mg, used to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction.
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