Mylan Pharmaceuticals has launched a fixed dose combination drug in India for treatment-experienced adults and adolescents weighing more than 40 kg with HIV-1.
The product, DURART R 450, comprises Darunavir/Ritonavir 400/50mg. Alternative treatments require patients to take two drugs separately. This is the first FDC drug available to patients in India, the company said in a release on Thursday.
President (India and Emerging Markets) Rakesh Bamzai said patients with HIV-1 will now have access to the fixed-dose combination therapy which may improve the overall patient treatment outcomes. Darunavir and Ritonavir are HIV protease inhibitors and can be used in combination for patients failing first and second-line regimens during the management of HIV-1 infection. Darunavir is currently available in India in 600 mg and 800 mg dose forms and Ritonavir is available in the 100 mg and 50 mg dose forms.
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The company’s ARV portfolio includes 14 APIs and 50 finished dosage forms in first-line, second-line and paediatric formulations, the release said.