Then, they seek FDA approval of a fixed-dose combination including that drug.

FORBES: Gilead Challenges FDA Over Exclusivity For Its Latest AIDS Drug

Ultimately, the biotech hopes the agency will change its interpretation of the law so that drugmakers would be encouraged to develop more fixed-dose combination drugs.

FORBES: Gilead Challenges FDA Over Exclusivity For Its Latest AIDS Drug

In its petition, the biotech notes that the FDA has denied exclusivity to 10 fixed-dose combination drugs containing both new and previously approved active moieties for nearly 20 years.

FORBES: Gilead Challenges FDA Over Exclusivity For Its Latest AIDS Drug

Currently, the FDA awards only three years of exclusivity if a fixed-dose combination drug contains a previously approved ingredient, and if a drugmaker conducted new clinical studies that were essential to approval.

FORBES: Gilead Challenges FDA Over Exclusivity For Its Latest AIDS Drug

The U.S. Food and Drug Administration today approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin.

FORBES: FDA Approves Juvisync, Combination of Sitagliptin and Simvastatin

The biotech wants the agency to change the way it grants exclusivity to fixed-dose combination drugs and hopes to win its argument so that more revenue can be wrung out of its recently approved Stribild HIV treatment.

FORBES: Gilead Challenges FDA Over Exclusivity For Its Latest AIDS Drug

"If used widely, this inexpensive, fixed-dose artemisinin-based combination antimalarial could make important contributions to 'rolling back malaria', " they wrote.

BBC: NEWS | Health | Drug cocktail 'may beat malaria'