The FDA has granted tentative approval for generic abacavir sulfate tabletsthe first generic version of Glaxo- SmithKline's Ziagen anti-HIV medication. The generic product will be manufactured by Aurobindo Pharma Ltd of Hyderabad, India, and will be available for consideration for purchase under the President's Emergency Plan for AIDS Relief.
The FDA's tentative approval of this product means that Aurobindo's product meets all of the FDA's manufacturing quality and clinical safety and efficacy standards. Although existing patents preclude marketing the new generic in the United States, the drug can be sold abroad and used under the President's plan.
One study linked multiple pregnancies to an increased risk of developing atrial fibrillation later in life, and another investigated the association between premature delivery and cardiovascular disease.
Clinical features with downloadable PDFs