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FDA gives Lupin OK for new generic, tentative nod for generic Triumeq

The FDA has given Lupin approval for generic Entresto, and tentative approval for generic Triumeq.
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approved medication

Lupin has received tentative permission from the Food and Drug Administration under the U.S. President’s Emergency Plan for AIDS Relief for abacavir, dolutegravir and lamivudine tablets for oral suspension, 60 mg/5 mg/30 mg, which is a generic of ViiV Healthcare’s Triumeq. 

Lupin will manufacture the product at its Nagpur facility in India and supply it to low- and middle-income countries.

The fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen, indicated for the treatment of HIV-1 infection in pediatric patients aged at least three months and weighing at least 6 kg.

[Read more: Lupin receives FDA OK for generic Banzel]

Ramesh Swaminathan, executive director, global CFO and head of API Plus SBU at Lupin said, “We are committed to providing affordable and high-quality treatments for patients worldwide. The tentative approval from the U.S. FDA for our Abacavir, Dolutegravir and Lamivudine Tablets enables us to improve the well-being of pediatric patients with HIV-1, thereby significantly boosting our HIV medication portfolio.”

Lupin also shared that it has received FDA approval for sacubitril and valsartan tablets, 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg, which is the generic of Novartis’ Entresto.

The medication is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction and for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.

[Read more: Lupin launches generic Minzoya]

Sacubitril and valsartan tablets, 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg, had a market value of roughly $6.06 billion, per IQVIA November 2024 data.

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