Ranbaxy announces new co-packaged triple ART combinations

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Indian pharmaceutical manufacturer Ranbaxy announced yesterday the launch of two new co-packaged triple combinations of d4T, 3TC and efavirenz, and AZT, 3TC and efavirenz. The company says that the co-packaging is designed to make the drugs easier to take, and each pack contains pictorial instructions on when to take the medication.

  • Virolis-E is a `compliance pack` containing two fixed dose combination tablets of lamivudine (3TC) 150mg and stavudine (d4T) 30/40mg and one tablet of efavirenz 600mg.
  • Virocomb-E is also a compliance pack and contains two fixed dose combination tablets of lamivudine (3TC) 150mg and zidovudine (AZT) 300mg and one tablet of efavirenz 600mg.

In most countries outside India, these products will be labeled and sold under the Coviro-E and Avocomb-E brand names respectively.

Glossary

compliance

An alternative term for ‘adherence’.

fixed-dose combination (FDC)

Two or more drugs contained in a single dosage form, such as a capsule or tablet. By reducing the number of pills a person must take each day, fixed-dose combination drugs may help improve adherence.

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

These products have not yet received pre-approval from the World Health Organization or tentative approval by the US Food and Drug Administration.

Efavirenz originators Merck and Bristol Myers Squibb are working with Gilead Sciences to coformulate efavirenz with tenofovir and emtricitabine (FTC) into one tablet, but the effort is proving challenging because of the large quantity of drug that must be pressed into tablets (the total daily dose of the three once-daily drugs amounts to 1100mg of drug).