Zydus Lifesciences (previously Cadila Healthcare) said that its US subsidiary Zydus Pharmaceuticals (USA) has secured final approval from the US Food and Drug Administration (FDA) for marketing Mirabegron Extended-Release Tablets USP 25 mg and 50 mg. The product is a generic of Myrbetriq, which has approval for the treatment of overactive bladder (OAB) with symptoms […]
Zydus Lifesciences Limited (previously Cadila Healthcare Limited) has bagged final approval for Sildenafil for Oral Suspension USP 10 mg/ml, its generic for Revatio, from the United States Food and Drug Administration (FDA). According to Zydus Lifesciences, Sildenafil for oral suspension is approved for the treatment of high blood pressure in the lungs (pulmonary hypertension). By […]
Indian pharma company Zydus Lifesciences Limited, previously known as Cadila Healthcare Limited has launched Lenalidomide Capsules, a generic of Revlimid, in the US market. The launch of Lenalidomide Capsules follows the final approvals for 5 mg, 10 mg, 15 mg and 25 mg strengths and tentative approvals for 2.5 mg and 20 mg strength from […]
Zydus Lifesciences (previously Cadila Healthcare) said that its American subsidiary Zydus Pharmaceuticals (USA) has secured tentative approval for Sugammadex Injection USP 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL), Single-Dose Vial from the US Food and Drug Administration (FDA). The product is a generic of Bridion (Sugammadex) of Merck. It has approval […]
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 (formerly known as Cadila Healthcare) said that the US Food and Drug Administration (FDA) completed an inspection of its Moraiya manufacturing plant in Ahmedabad with four Form 483 observations. The FDA inspection was held from 26 July and 5 August 2022. Zydus Lifesciences said that none of the observations made by the FDA […]
Zydus Lifesciences (previously called Cadila Healthcare) has secured final approval for antiparasitic ointment Ivermectin Cream, 1% from the US Food and Drug Administration (FDA). Ivermectin Cream, 1% is the generic of Soolantra, which is used for treating inflammatory lesions of rosacea. Zydus Lifesciences will manufacture Ivermectin Cream at its topical manufacturing facility in Ahmedabad, India. […]
Zydus Lifesciences (Cadila Healthcare) has rolled out the molecule Sitagliptin in India under the Sitaglyn and Siglyn brand names for the treatment of Type 2 diabetes in the country. Sitaglyn and Siglyn are intended to be delivered as an oral solution. According to Zydus Lifesciences, Sitaglyn drug is said to offer best-in-class achievement of the […]
Zydus Lifesciences (previously Cadila Healthcare) said that it has secured final approval from the US Food and Drug Administration (FDA) for marketing Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%. The product is a generic of Epiduo Forte. It is a combination of Adapalene, which is a retinoid, and Benzoyl Peroxide, which is an antibiotic and […]
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 […]