Zydus Cadila gets FDA tentative approval for Cariprazine Capsules

Zydus Cadila gets FDA tentative approval for Cariprazine Capsules

Zydus Cadila said that its subsidiary Zydus Pharmaceuticals (USA) has secured tentative approval from the US Food and Drug Administration (FDA) to commercialize Cariprazine Capsules in the strengths of 1.5 mg, 3 mg, and 4.5 mg, and 6 mg. The reference listed rug (RLD) of Cariprazine Capsules is VRAYLAR. Cariprazine, which is an atypical antipsychotic, […]

Zydus Cadila gets FDA final approval for Decitabine injection

Zydus Cadila gets FDA final approval for Decitabine injection

Zydus Cadila has secured final approval from the US Food and Drug Administration (FDA) for the commercialization of the cancer medication Decitabine for Injection in the strength of 50mg/vial Single-Dose Vial. Decitabine for Injection is a generic of Dacogen, which is approved for the treatment of myelodysplastic syndromes, some types of blood or bone marrow […]

Zydus Cadila begins EVIDENCES-X phase 2b NASH trial of Saroglitazar Mg

Zydus Cadila begins EVIDENCES-X phase 2b NASH trial of Saroglitazar Mg

Zydus Cadila (Cadila Healthcare) has dosed the first patient in the EVIDENCES-X phase 2b clinical trial of Saroglitazar Magnesium (Saroglitazar Mg) in non-alcoholic steatohepatitis (NASH). The multi-centre, randomized, double-blind, placebo-controlled trial will assess the safety and efficacy of Saroglitazar Magnesium in patients with NASH and fibrosis. The EVIDENCES-X clinical trial will randomly group 240 patients […]

Zydus Cadila gets FDA tentative approval for acne treatment generic

Zydus Cadila gets FDA tentative approval for acne treatment generic

Zydus Cadila has secured tentative approval from the US Food and Drug Administration (FDA) for marketing Adapalene and Benzoyl Peroxide Gel 0.3%/2.5%. A generic of Galderma’s Epiduo Forte, Adapalene and Benzoyl Peroxide Gel 0.3%/2.5% is intended for the treatment of acne. The combination of adapalene and benzoyl peroxide works by destroying the bacteria that cause […]

Zydus Cadila gets FDA approval for Apremilast Tablets

Zydus Cadila gets FDA approval for Apremilast Tablets

Zydus Cadila said that its subsidiary Zydus Pharmaceuticals (USA) has secured final approval from the US Food and Drug Administration (FDA) to market Apremilast Tablets, a drug for psoriasis. The approval is for the strengths of 10 mg, 20 mg, and 30 mg. Apremilast Tablets is a generic of Otezla Tablets, which is indicated for […]

Zydus Cadila gets FDA’s final approval for Vortioxetine Tablets

Zydus Cadila gets FDA’s final approval for Vortioxetine Tablets

Zydus Cadila has secured final approval from the US Food and Drug Administration (FDA) to market Vortioxetine Tablets in the strengths of 5mg, 10mg, 20mg for the treatment of depression. The reference listed drug (RLD) of Vortioxetine Tablets is Trintellix Tablets in the US. Vortioxetine is a selective serotonin reuptake inhibitor (SSRI) and serotonin receptor […]