February 10, 2010

Abbott is pleased to announce the U.S. Food and Drug Administration (FDA) approval of the new tablet formulation of our protease inhibitor (PI) Norvir (ritonavir). This new heat-stable formulation can be stored at room temperature and does not require refrigeration, making it more convenient for patients.

Norvir Tablet and Meltrex

Abbott developed the technology known as Meltrex that makes the Norvir tablet possible. Even though the Meltrex technology exists in Kaletra (lopinavir/ritonavir) it took several years and extensive clinical work to develop the Norvir tablet for FDA approval. The time and investment in development were well spent for patients and physicians, and in the coming weeks the Norvir tablet will be available in pharmacies across the country. The new Norvir tablet and the Norvir soft-gelatin capsule both contain 100 mg of ritonavir. While the rate of drug absorbed is different, there is no requirement for dosage change. All forms of Norvir remain on the market, including the soft-gelatin capsule and liquid.

Pricing, Access, and the Norvir Tablet

Abbott will launch the Norvir tablet at the same wholesale acquisition (WAC) price as the soft-gel capsules.

To further help patients access this important new formulation of Norvir, Abbott is launching a Norvir co-pay support program, which will be available through Norvir.com. The co-pay program will be available for all formulations of Norvir. Once a patient has paid $25 in co-pays, this program will cover up to $75 per month in patient co-pays within the first 12 months. Certain restrictions may apply.

Abbott's patient assistance program will continue to make sure that any patient without prescription coverage can get Norvir for free, regardless of their financial status. The Patient Assistance Program also provides Norvir free of charge to any ADAP-eligible patient on a waiting list, to anyone who has exceeded his or her coverage maximum for annual prescription drug benefits, and to those patients on 400 mg a day or more.

Abbott also offers several patient assistance programs that provide Kaletra and Norvir at no cost to patients experiencing financial difficulties. To learn more about other programs assisting patients in need, visit Abbott's Patient Assistance Programs overview online or call Abbott's patient access toll-free number at 1-800-222-6885, option 4.

Please click here for Norvir full Prescribing Information.

Summarized below are excerpts from the new Norvir Tablet package insert highlighted by the FDA:

Unlike the capsule formulation, Norvir tablets must be taken with meals. As a result, Section 2 - DOSAGE AND ADMINISTRATION contains the following information specific to the tablet formulation.

NORVIR is administered orally. NORVIR tablets should be swallowed whole, and not chewed, broken or crushed.

General Dosing Guidelines

Patients who take the 600 mg twice daily soft gel capsule NORVIR dose may experience more gastrointestinal side effects such as nausea, vomiting, abdominal pain or diarrhea when switching from the soft gel capsule to the tablet formulation because of greater maximum plasma concentration (Cmax) achieved with the tablet formulation relative to the soft gel capsule [see Clinical Pharmacology (12.3)]. Patients should also be aware that these adverse events (gastrointestinal or paresthesias) may diminish as therapy is continued.

Dose Modification for NORVIR

Dose reduction of NORVIR is necessary when used with other protease inhibitors: amprenavir, atazanavir, darunavir, fosamprenavir, saquinavir, and tipranavir. Prescribers should consult the full prescribing information and clinical study information of these protease inhibitors if they are co-administered with a reduced dose of ritonavir.

2.1 Adult Patients

Recommended Dosage for Treatment of HIV-1.

The recommended dosage of ritonavir is 600 mg twice daily by mouth to be taken with meals.

In Section 12.3 - Pharmacokinetics, the following information regarding the tablet formulation was included.

Absorption

NORVIR tablets are not bioequivalent to NORVIR capsules. Under moderate fat conditions (857 kcal; 31% fat, 13% protein, 56% carbohydrates), when a single 100 mg NORVIR dose was administered as a tablet compared with a capsule, AUC(0-infinity) met equivalence criteria but mean Cmax was increased by 26% (92.8% confidence intervals: 15 -39%).

No information is available comparing NORVIR tablets to NORVIR capsules under fasting conditions

Effect of Food on Oral Absorption

A food effect is observed for NORVIR tablets. Food decreased the bioavailability of the ritonavir tablets when a single 100 mg dose of NORVIR was administered. Under high fat conditions (907 kcal; 52% fat, 15% protein, 33% carbohydrates), a 23% decrease in mean AUC(0-infinity) [90% confidence intervals: 30%-15%], and a 23% decrease in mean Cmax [90% confidence intervals: 34%-11%]) was observed relative to fasting conditions. Under moderate fat conditions, a 21% decrease in mean AUC(0-infinity) [90% confidence intervals: 28%-13%], and a 22% decrease in mean Cmax [90% confidence intervals: 33%-9%]) was observed relative to fasting conditions.

However, the type of meal administered did not change ritonavir tablet bioavailability when high fat was compared to moderate fat meals.

Section 16 - HOW SUPPLIED/STORAGE AND HANDLING is updated to contain the following information:

16.1 NORVIR Tablets, 100 mg Ritonavir

NORVIR (ritonavir) tablets are white film-coated ovaloid tablets debossed with the corporate Abbott "A" logo and the Abbo-Code NK.

Bottles of 30 tablets each (NDC 0074-3333-30).

Recommended Storage

Store NORVIR film-coated tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP controlled room temperature]. Dispense in original container or USP equivalent tight container (60 mL or less). For patient use: exposure of this product to high humidity outside the original or USP equivalent tight container (60 mL or less) for longer than 2 weeks is not recommended.