FDA Approves Oraquick HIV-1/2 Antibody Test, Follistim AQ Cartridge, Viewpoint CK System, and Chewable Zyrtec

Yael Waknine

March 25, 2004 — The U.S. Food and Drug Administration (FDA) recently approved an HIV test, a fertility device, a keratoplasty procedure, and a chewable antihistamine for children.

Oraquick Rapid HIV-1/2 Antibody Test for the Detection of HIV

OraSure Technology received FDA approval yesterday for its Oraquick Rapid HIV-1/2 Antibody test, which provides simultaneous detection of antibodies to both HIV-1 and HIV-2 in finger stick and venipuncture whole blood specimens.

The single rapid test for both strains may allow for broader detection, treatment, and prevention of HIV/AIDS. "This is particularly important in the higher prevalence urban areas here in the United States where HIV-2 infection is more likely to occur and in many foreign countries where HIV-2 testing is required as part of the normal testing regimen," says Mike Gausling, president and chief executive officer of OraSure, in a news release.

Follistim AQ Cartridge for Delivery of FSH

The Follistim AQ cartridge received FDA approval this week for use with the Follistim pen in self-administered, individualized dose injections of premixed follitropin beta, a follicle-stimulating hormone (FSH) made from recombinant DNA technology used in fertility treatments.

The Follistim AQ cartridge used with the pen is prescribed for women undergoing assisted reproductive treatments such as in vitro fertilization, and for the induction of ovulation to achieve pregnancy.

The cartridge, available in strengths of 300 IU and 600 IU, provides physicians with the flexibility to fine-tune individual drug protocols for patients. Self-injection is safe, and the accurate dosing delivers on average an 18% higher amount of follitropin beta compared with lyophilized preparations administered by a conventional syringe and needle, according to a news release from Organon, the maker of the cartridge.

"Fertility treatment can create anxiety for patients, in large part because they have to mix, measure, and inject the medicine themselves," Samuel Pang, MD, associate medical director of the Reproductive Science Center in Boston, Massachusetts and investigator in the Follistim clinical trials, says in the news release. "This innovative method of delivering FSH makes the process go smoothly, because the medication is already mixed and the patient just has to dial the correct dose. Also, the microneedle and small volume of injection may contribute to patient tolerability of the injection."

Viewpoint CK System for Presbyopia

The Viewpoint CK system for performing the NearVision conductive keratoplasty procedure was approved by the FDA this week for the temporary improvement of near vision due to emmetropic and hyperopic presbyopia. The system is made by Refractec.

Presbyopia, or loss of near vision, is an age-related condition affecting most people after age 40 years, and all people by age 51 years.

"Presbyopia is the one inescapable vision disorder that will eventually affect us all," says Daniel S. Durrie, MD, from the University of Kansas and medical monitor for the FDA clinical trial of presbyopia, in a company news release. "The frustration many people feel with the on-again, off-again annoyance of reading glasses cannot be overemphasized. NearVision is just what baby boomers have been waiting for to help them get rid of their reading glasses and safely see like they did when they were young."

Conductive keratoplasty is a safe, minimally invasive, non-laser procedure for patients who now require reading glasses to compensate for fading near vision. The procedure is painless and takes about three minutes in an outpatient setting. The procedure improves near vision without compromising the patient's binocular distance vision.

The procedure is performed using a small probe, thinner than a strand of human hair, that releases radio waves. The probe is applied in a circular motion on the outer cornea to shrink small areas of collagen, creating a constrictive band that increases the overall curvature of the cornea and brings near vision back into focus.

The FDA based its approval on clinical trial data collected at one year after conductive keratoplasty. At that time, 98% of patients could see J5 (newspaper-size print) with the corrected eye, while 87% of patients could see 20/20 in the distance and also read J3 (phonebook-size print).

Zyrtec Chewable for Seasonal and Chronic Allergic Rhinitis

A new chewable formulation of cetirizine hydrochloride (Zyrtec) was approved by the FDA this month for the treatment of seasonal and chronic allergic rhinitis and chronic idiopathic urticaria in children aged 2 years and older. The new formulation is made by Pfizer.

The chewable formulation of cetirizine is aimed at children aged six to 12 years who are too young to swallow tablets.

The grape-flavored tablets are taken once daily with or without food or water, and are available in 5-mg and 10-mg doses for flexibility in age-related dosing.

"This new chewable formulation provides more convenience and flexibility for a trusted antihistamine," says Gail Shapiro, MD, in a company news release. Dr. Shapiro is an allergist at the University of Washington School of Medicine in St. Louis, Missouri, and past president of the American Academy of Allergy, Asthma and Immunology.

Reviewed by Charlotte Grayson, MD

Yael Waknine is a freelance writer for Medscape.
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