FDA approves Cipla’s HIV-1 generic

FDA approves Cipla’s HIV-1 generic

MUMBAI, India — Cipla received Food and Drug Administration approval for its Abbreviated New Drug Application for Abacavir and Lamivudine Tablets USP, 600 mg/300 mg, from the Abacavir and Lamivudine Tablets USP, 600 mg/300 mg, are AB-rated generic equivalents to the reference listed drug, Epzicom Tablets, 600 mg/300 mg of ViiV Healthcare and are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Epzicom Tablets had sales of approximately $346.3 million for the 12-month period ended February 2017, according to IMS Health.

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April 6, 2017 / Pharma News