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 (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 (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 (previously called Cadila Healthcare) said that its subsidiary Zydus Worldwide DMCC has been given tentative approval from the US Food and Drug Administration (FDA) for Valbenazine Capsules USP 40 mg, 60 mg, and 80 mg. The product is a generic of Neurocrine Biosciences’ Ingrezza, which was approved by the FDA in 2017. According […]
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 (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 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) 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 […]
Zydus (Cadila Healthcare) has secured final approval from the US Food and Drug Administration (FDA) to market Vigabatrin Tablets in the strength of 500mg. Vigabatrin Tablets is the generic version of Sabril Tablets. It is indicated in the US for the treatment of babies, aged one month to two years, having infantile spasms. The drug […]