FDA gives Lupin tentative nod for generic Symtuza
Generic Symtuza is used to treat HIV.
Lupin has received tentative approval from the Food and Drug Administration for darunavir, cobicistat, emtricitabine, and tenofovir alafenamide tablets, 800 mg/150 mg/200 mg/10 mg, which is the generic of Janssen’s Symtuza.
The medication is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 infection in adults and in children who weigh at least 88 pounds (40 kg) and who:
- Have not received anti-HIV-1 medicines in the past, or
- When their healthcare provider determines that they meet certain requirements.
Lupin said it is the exclusive first-to-file for this product. The product will be manufactured at Lupin’s Nagpur facility in India.
[Read more: FDA gives Lupin OK for new generic, tentative nod for generic Triumeq]
The medication had a market value of roughly $1.4 billion, per IQVIA December 2024 data.
