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FDA Grants Tentative Approval of Triumeq PD Generic for Children with HIV

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With this tentative approval of abacavir/dolutegravir/lamivudine, Viatris aims to help adherence to HIV treatment in low- and middle-income countries.

The FDA has granted tentative approval for Viatris’ abacavir/dolutegravir/lamivudine for oral suspension to treat HIV-1 infection in children. It is the generic of ViiV Healthcare’s Triumeq PD, which the FDA approved in March 2022.

The tentative approval is through the President’s Emergency Plan for AIDS Relief (PEPFAR) program. Viatris has signed a licensing agreement for pediatric dolutegravir from the Medicines Patent Pool and development agreement with ViiV Healthcare and the Clinton Health Access Initiative for producing and distributing the fixed-dose combination of abacavir/ dolutegravir/lamivudine. The tentative approval facilitates regulatory authority submissions, production and distribution across 123 low- and middle-income countries.

The World Health Organization recommends abacavir/dolutegravir/lamivudine as a preferred first-line regimen for pediatric patients. According to the Joint United Nations Program on HIV/AIDS, about 660,000 children living with HIV – about 43% of the estimated total 1.5 million children living with HIV – did not receive antiretroviral (ARV) therapy in 2022.

Rakesh Bamzai

Rakesh Bamzai

“The approval of this single tablet regimen – the fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg — will reduce the pill burden for children living with HIV,” Rakesh Bamzai, president of India, Emerging Asia & Access Markets at Viatris, said in a press release.

Abacavir/dolutegravir/lamivudine is a fixed-dose combination containing two nucleoside reverse transcriptase inhibitors (NRTIs) and integrase strand transfer inhibitor (INSTI). NRTIs interfere with the action of the reverse transcriptase enzyme and INSTI interferes with the action of integrase enzyme to prevent the virus from replicating.

In other generic news:

  • The FDA has approved Mallinckrodt’s Lisdexamfetamine Dimesylate capsules, the generic equivalent to Takeda’s Vyvanse capsules, to treat patients with attention-deficit/hyperactivity disorder (ADHD). Vyvanse is on the FDA’s shortage list. Mallinckrodt’s drug was approved for all seven strengths. It will be sold through Mallinckrodt’s specialty generics segment, SpecGx.
  • Upsher-Smith has launched two generic therapies: Mesalamine Extended-Release capsules, the generic equivalent to Apriso, which is used to treat patients with ulcerative colitis; and Famotidine Oral Suspension, the generic equivalent of Pepcid, which is used to treat heartburn, ulcers and gastroesophageal reflux disease (GERD).
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