FDA grants interim approval for Mylan’s TLD formulation

Mylan's TLD formulation is the first fixed-dose combination of its type to be distributed specifically for HIV/AIDS.
Mylan's TLD formulation is the first fixed-dose combination of its type to be distributed specifically for HIV/AIDS. | File photo

International pharmaceutical provider Mylan recently obtained what it called tentative approval of its New Drug Application (NDA) for an antiretroviral (ARV) formula to circulate as a preferred treatment for HIV/AIDS patients in developing nations.

The product attained approval from the U.S. Food and Drug Administration under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) and is the first fixed-dose combination of its type to be distributed specifically for HIV/AIDS.

The full formulation — Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 50 mg/300 mg/300 mg (TDF-3TC-DTG) — is referred to as TLD and combines molecules from three source medications.

"Our innovative TLD is a new medicine that will be available specifically to patients in the developing world being treated for HIV/AIDS,” Mylan President Rajiv Malik said. “We know the challenges they face accessing high quality, affordable ARVs. That's why our scientists worked diligently to develop a medicine that combines three of the leading first-line regimens into a new, smaller tablet that patients have to take only once each day."

The World Health Organization (WHO) suggested in July that national programs consider the combination based on its relatively high tolerability, efficacy, demonstrated consistency in treatment maintenance, and fewer drug interactions.

Mylar provides ARVs to almost half of patients undergoing HIV/AIDS treatment in over 100 developing countries.

The company strives to bring treatment to underserved populations worldwide.

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