Lupin Receives FDA Approval For Pediatric HIV Generic Tablets For Oral Suspension

Lupin Limited is a prominent international player in the pharma industrial sector, which reveals that it has received tentative approval from the U.S. Food and Drug Administration (FDA). The approval is for its Abbreviated New Drug Application  (ANDA) for generic Triumeq PD® Tablets for Oral Suspension. This product combines Abacavir 60 mg + Dolutegravir 5 mg + Lamivudine 30 mg. The compound is developed for use in HIV-1 treatment in the pediatric population of patients aged 3 months and more and with a weight not less than 6 kgs.

The generic medication will be in a once-daily single-pill formulation and manufactured in Lupin’s limited facility in Nagpur, India. Triumeq PD®, its branded equivalent as per IQVIA for the 12 months ending September 2024, was approximately $1.3 million for the U.S.