Cipla gets final USFDA nod to sell generic Abacavir and Lamivudine tablets

Cipla, a global pharmaceutical company, announced on Tuesday that it has received final approval for its Abbreviated New Drug Application (ANDA) for Abacavir and Lamivudine tablets USP, 600 mg/300 mg, from the United States Food and Drug Administration (USFDA). The product is generic version of ViiV Healthcare Company's Epzicom tablets in the same strengths.

Abacavir and Lamivudine tablets USP, 600 mg/300 mg, are AB-rated generic equivalents to the reference listed drug (RLD), Epzicom tablets, 600 mg/300 mg of ViiV Healthcare Company and are indicated in combination with other anti-retroviral agents for the treatment of HIV-1 infection.

Epzicom, which is a combination of Abacavir and Lamivudine tablets USP, 600 mg/300 mg, is indicated in conjunction with other anti-retroviral agents for the treatment of HIV-1 infection.

Epzicom tablets had US sales of approximately $346.3 mn for the 12-month period ending February 2017, according to IMS Health. The product will cater to the US market and will be commercially available shortly. Cipla gets export revenue of 15.4% from the US markets, which is expected to grow supported by this approval.

Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. The company’s portfolio includes over 1,000 products across wide range of therapeutic categories with one quality standard globally.