"The tentative approval from the USFDA for our Abacavir, Dolutegravir and Lamivudine Tablets enables us to improve the well-being of pediatric patients with HIV-1, thereby significantly boosting our ...

The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Ivacaftor oral granules of strengths 25 mg, 50 mg, and 75 mg per unit dose packet, ...