Zydus advances PCSK9 inhibitor with Phase I clinical study approval

Zydus advances PCSK9 inhibitor with Phase I clinical study approval

Zydus, a global pharmaceutical company, has secured permission from CDSCO, India, to kickstart the Phase I clinical study of its groundbreaking PCSK9 inhibitor. This Phase I study, characterized by its prospective, randomized, double-blind, and placebo-controlled design, is poised to explore the safety and tolerability of the subcutaneously administered anti-PCSK9 product in healthy human volunteers. Cardiovascular […]

Zydus Lifesciences gets FDA approval for Estradiol Transdermal System

Zydus Lifesciences gets FDA approval for Estradiol Transdermal System

Zydus Lifesciences (previously Cadila Healthcare) has secured final approval for Estradiol Transdermal System USP, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day from the US Food and Drug Administration (FDA). The approved product is a generic version of Vivelle-Dot Transdermal System. Estradiol Transdermal System has FDA approval for the treatment of moderate […]

Zydus Lifesciences gets FDA final approval for Micafungin for Injection

Zydus Lifesciences gets FDA final approval for Micafungin for Injection

Zydus Lifesciences (formerly Cadila Healthcare) has secured final approval for Micafungin for Injection, 50 mg/vial and 100 mg/vial, single-dose vials from the US Food and Drug Administration (FDA). The product is the generic version of Mycamine, and has approval for the treatment of a range of fungal infections. Besides, Micafungin for Injection, 50 mg/vial and […]

Zydus Lifesciences bags FDA approval for Cariprazine generic

Zydus Lifesciences bags FDA approval for Cariprazine generic

Zydus Lifesciences (previously Cadila Healthcare) said that its American subsidiary — Zydus Pharmaceuticals (USA) has secured final approval from the US Food and Drug Administration (FDA) for Cariprazine Capsules, USP 1.5 mg, 3 mg, 4.5 mg, and 6 mg. In December 2021, Zydus Lifesciences was given tentative approval from the FDA for the drug product. […]

Zydus Lifesciences gets FDA approval for Bortezomib for Injection

Zydus Lifesciences gets FDA approval for Bortezomib for Injection

Zydus Lifesciences (previously called Cadila Healthcare) said that it has secured final approval from the US Food and Drug Administration (FDA) to market Bortezomib for Injection, 3.5 mg/vial, Single-Dose Vial. Bortezomib for Injection is the generic of Velcade (bortezomib), which has a market size of $1.17bn as per IQVIA MAT March 2022. It is used […]

Zydus gets FDA approval for COPD drug Roflumilast Tablets

Zydus gets FDA approval for COPD drug Roflumilast Tablets

Zydus Group said that its subsidiary Zydus Pharmaceuticals (USA) has secured final approval from the US Food and Drug Administration (FDA) to market Roflumilast Tablets in 500mcg strength and tentative approval for Roflumilast Tablets in 250mcg. Roflumilast Tablets is the generic version of Dalires. Zydus said that as it is one of the first applicants […]

Cadila Healthcare (Zydus) begins supply of ZyCoV-D vaccine to Indian govt

Cadila Healthcare (Zydus) begins supply of ZyCoV-D vaccine to Indian govt

Cadila Healthcare (Zydus) said that it has commenced the supplies of ZyCoV-D, the company’s Covid-19 vaccine to the Indian government. The first consignment of the ZyCoV-D vaccine has been delivered already from the company’s newly commissioned Zydus Vaccine Technology Excellence Centre at the Zydus Biotech Park in Changodar, Ahmedabad. It can be noted that Zydus […]