FDA Approves Generic Drug Combination For HIV-1

The Food and Drug Administration (FDA) published consumer guidance, notifying the public that the agency has approved a generic drug combination for HIV-1 infection. Lamivudine tablets (150 mg) and zidovudine tablets (300 mg) are made by Hetero Labs Limited in India. The FDA declared the generics to be bioequivalent to the branded drug Combivir from GlaxoSmithKline. FDA approval clears the way for Hetero Labs to market the generics in the U.S. Generic drugs for HIV and other conditions are listed on the FDA website.

HIV-1

HIV-1 is a strain of human immunodeficiency virus (HIV). The HIV virus mutates into strains and an infected person may have several different strains. Virus strains are categorized according to genetic types and subtypes. HIV-1 is transmitted by sexual contact, from mother to child, and through contaminated blood. HIV-1 is clinically the same as HIV-2, but HIV-1 is easier to transmit and quicker to turn from infection to illness. HIV-1 is most common globally.

Lamivudine and Zidovudine

Lamivudine and zidovudine are two active antiviral medications for HIV in children and adults. They are used in combination with other antiviral medications, known as antiretrovirals. These nucleoside analogue reverse transcriptase inhibitors (NRTIs), also called nucleoside analogues, trick the HIV cell into not reproducing. When HIV invades a cell, it copies its DNA, programming the cell to make more copies.  The nucleoside analogues alter the DNA replication process, slowing the spread of the virus.

Generic Drug Approvals

Generic drugs are copies or bioequivalents of brand name drugs. Generics are the same substance or compound, have the same safety profile, drug concentration and dose, and similar method of administration. The FDA approves generic drugs because the agency believes they provide better health care for Americans. Generics go through a rigorous screening so patients and doctors can be sure that the products are safe and effective. The agency says that eight in ten prescriptions written in the U.S. are for generic drugs. Generics are expected to increase as patented drugs lose their exclusivity.

About Hetero Labs Limited

Hetero is a pharmaceutical company with a global reach. Established in 1993, the company has a portfolio of over 200 products. Products include ingredients and finished doses. The company markets its products in over 138 companies.

Source:

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm384582.htm