Oral Tipranavir Receives Expanded Indication
The FDA approved tipranavir (Aptivus) capsules or oral solution with dosing information for treatment-experienced pediatric patients between the ages of 2 and 18 who are infected with HIV. The oral solution formulation was also approved for treatment-experienced adults.
Aptivus, a protease inhibitor, is coadministered with ritonavir and is indicated for combination antiretroviral treatment of HIV-1 infected patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor.
Consult product labeling for prescribing details and important safety precautions.
Tablet Formulation of Venlafaxine Approved
The FDA approved Osmotica Pharmaceutical's formulation for extended-release venlafaxine for the treatment of major depressive disorder and social anxiety disorder. The generic tablet strengths of 37.5 mg, 75 mg, and 150 mg are bioequivalent to the brand-name (Effexor XR) capsules at 37.5 mg, 75 mg, and 150 mg when administered under FDA approved conditions. A 225-mg tablet has also been approved, which is the maximum recommended dose used for major depressive disorder. This is a previously unavailable dosage strength.
These capsules are not approved for use in pediatric patients. For complete prescribing information, consult product labeling.
New Combination Vaccine for Children Available
GlaxoSmithKline has received FDA approval for KINRIX, a combination vaccine that offers protection against diphtheria, tetanus, pertussis, and polio. With the introduction of KINRIX, children can receive protection against four serious diseases with one less shot.
KINRIX is indicated for children 4 to 6 years of age whose previous diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccinations have been with PEDIARIX.
Clinical studies have demonstrated that this new combination vaccine offers similar protection to the separately administered DTaP and IPV vaccines, with a comparable safety profile.
KINRIX contains the same DTaP and IPV components used in INFANRIX and PEDIATRIX.
Atralin Gel Enhances Tretinoin's Effectiveness
Coria Laboratories' Atralin (tretinoin) Gel 0.05% formulation is available to treat acne vulgaris. It enhances the action of tretinoin against the papules and pustules of acne, and combines the moisturizing and hydrating ingredients to help counteract skin dryness and irritation. Atralin Gel's micronized formulation also helps tretinoin penetrate the skin, while its vehicle components encourage patients to use the therapy.
The most common adverse reactions reported with use of Atralin Gel were mild-to-moderate irritation of the skin, which occurred during the first few weeks of treatment.
Atralin Gel can be applied under makeup. Patients using this product should protect their skin from the sun, tanning lights, extreme wind or cold, and harsh skin care products.
Morphine Sulfate Extended-release Tablets Recalled
ETHEX Corporation notified healthcare providers of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (lot number 91762) because of a report of a tablet with twice the appropriate thickness.
The oversized tablets may contain as much as two times the labeled level of active morphine sulfate. Opioids such as morphine have life-threatening consequences if overdosed, the FDA notes. The agency further points out that many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness, and may be less likely to realize that a tablet is oversized.
The lot was distributed by ETHEX under the "ETHEX" label between April 16 and April 27 of this year.