The morale of people fighting against Acquired Immuno Deficiency Syndrome (AIDS) got a boost when the USFDA (Food and Drug Administration) gave its tentative approval for three generic AIDS drugs.
Aurobindo Pharma Ltd, of Hyderabad, India has been authorized to manufacture the generic version of Abacavir Sulfate Oral Solution with 20 mg (base)/mL. The drug is otherwise sold by GlaxoSmithKline under the name of Ziagen Oral Solution. The formulation is intended for children between the ages of three months and 13 years who are infected with the Human immunodeficiency virus (HIV). The approval is a good news as it means that thousands of children covered by the US President's Emergency Plan for AIDS Relief (PEPFAR) will now get access to the drug.
Aurobindo Pharma was granted tentative approval by the USFDA also for stavudine 15 and 20 mg capsules. The drug is a generic version of Zerit, sold by Bristol Myers-Squibb. As in the case of abacavir, the tentative approval does not allow the drug to be marketed in the US. because of existing patents and/or exclusivity rights. Stavudine fights AIDS by preventing the virus from reproducing.
However, Aurobindo is receiving stiff competition from Cipla Ltd. Cipla has got tentative approval from the USFDA for its abbreviated new drug application (ANDA) for anti-HIV/AIDS drug Slamivudine. The approval is for the oral solution of strength 10 mg per ml. The active ingredient in the formulation is lamivudine. The announcement caused Cipla’s shares to rise 1.6 per cent.
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