Pharmacy Times

rx PRODUCT news


Aptivus


Marketed by:
Boehringer Ingelheim Pharmaceuticals Inc (Ridgefield, CT)

Indication:
October 5, 2007—Boehringer Ingelheim Pharmaceuticals Inc announced that it received full (traditional) FDA approval of Aptivus (tipranavir) capsules. The FDA granted accelerated approval to Aptivus in June 2005; accelerated approval is a regulatory process that expedites the approval of therapies for serious or life-threatening illnesses. Aptivus, a protease inhibitor, co-administered with 200 mg of ritonavir (Aptivus/r), is indicated for combination antiretroviral treatment of HIV-1?infected adult patients who are treatment-experienced and infected with HIV-1 strains resistant to >1 protease inhibitor. The use of Aptivus in treatmentna?ve patients is not recommended.

Dosage Form:
Capsules: 250 mg

For More Information:
www.aptivus.com


Flo-Pred


Marketed by:
Taro Pharmaceuticals USA Inc (Hawthorne, NY)

Indication:
January 22, 2008—Taro Pharmaceutical Industries Ltd reported that its US affiliate, Taro Pharmaceuticals USA Inc, received FDA approval for its new drug application for Flo-Pred (prednisolone acetate oral suspension) equivalent to 5 mg/5 mL and 15 mg/5 mL prednisolone in Taro's patent-protected NonSpil liquid drug delivery system. Flo-Pred is an anti-inflammatory agent for the treatment of asthma, certain allergic and dermatologic conditions, as well as a variety of other indications. Flo-Pred does not require refrigeration and does not require shaking prior to use. The patent-protected, taste-masking formula has a cherry flavor, which may be helpful in administering the product to children.

Dosage Form:
Oral suspension: 5 mg/5 mL and 15 mg/5 mL

For More Information:
www.taro.com


INTELENCE


Marketed by:
Tibotec Therapeutics, a division of Ortho Biotech Products LP (Bridgewater, NJ)

Indication:
January 18, 2008—The FDA has granted accelerated approval to INTELENCE (etravirine) tablets. INTELENCE, in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 in antiretroviral treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to a nonnucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents. INTELENCE is the first new NNRTI to be introduced in nearly 10 years. NNRTIs block reverse transcriptase, a key enzyme that HIV uses to replicate.

Dosage Form:
Tablets: 100 mg

For More Information:
www.INTELENCE-info.com


SYMLIN


Marketed by:
Amylin Pharmaceuticals Inc (San Diego, CA)

Indication:
October 1, 2007?Amylin Pharmaceuticals Inc received FDA approval of the SymlinPen 120 and the SymlinPen 60 pen-injector devices for administering SYMLIN (pramlintide acetate) injection. These new prefilled pen-injector devices feature simple, fixed dosing to improve mealtime glucose control. SymlinPen 60 features fixed dosing to deliver 15, 30, 45, or 60 mcg/dose. SymlinPen 120 features fixed dosing to deliver 60 or 120 mcg/dose. Both pen-injector devices can be conveniently stored at room temperature not to exceed 86?F (30?C) after first use. SYMLIN is an antihyperglycemic drug given at mealtimes for use in patients with diabetes treated with insulin.

Dosage Form:
SymlinPen 60: 15, 30, 45, or 60 mcg/dose; SymlinPen 120: 60 or 120 mcg/dose

For More Information:
www.symlin.com
800-349-8919

Hot Rx

AmniScreen Home Detection Liner Kit

Marketed by:
Duramed Pharmaceuticals Inc (Pomona, NY), a subsidiary of Barr Pharmaceuticals Inc

Indication:
January 28, 2008—The AmniScreen Home Detection Liner Kit, from Duramed Pharmaceuticals, was FDA approved as an at-home test to be used as an aid for detecting amniotic fluid leakage in pregnant women experiencing unexplained vaginal wetness. The kit, available by prescription only, contains 3 testing panty liners (TPL) and 3 drying trays. The TPL is a regular panty liner with an indicator strip assembled into the panty liner, covered with 2 layers of a 1-way perforated film. The kit is intended to detect possible leakage of amniotic fluid by indicating pH level (amniotic fluid normally has pH levels of 6.5-7.5 units). If pH levels are ≥5.2, the TPL will produce a blue?green color. Patients are instructed to report or show test results to their health care provider for interpretation and medical care.

Dosage Form:
Kit contains: 3 testing panty liners; 3 drying trays; instructions for use

For More Information:
www.amniscreen.com



Tekturna HCT


Marketed by:
Novartis Pharmaceuticals Corp (East Hanover, NJ)

Indication:
January 21, 2008—Tekturna HCT (aliskiren and hydrochlorothiazide) was FDA approved as a single- tablet combination of 2 high blood pressure medicines: Tekturna (aliskiren), the first new type of high blood pressure medicine in more than a decade, and the diuretic hydrochlorothiazide (HCT). The 2 medicines in this single-tablet combination work together to lower blood pressure, with clinical data showing that the combination of Tekturna and HCT offers greater blood pressure reductions than either component alone. Tekturna HCT is approved for patients not controlled by either medicine alone but should not be used before other medications have been tried first.

Dosage Form:
Tablets (mg aliskiren/mg HCT): 150/12.5, 150/25, 300/12.5, 300/25

For More Information:
www.tekturnahct.com
888-NOW-NOVA (888-669-6682)


Vyvanse


Marketed by:
Shire plc (Philadelphia, PA)

Indication:
January 3, 2008—Shire plc announced that it received FDA approval for 3 additional dosage strengths for Vyvanse (lisdexamfetamine dimesylate). Vyvanse is indicated for the treatment of attention-deficit/hyperactivity disorder. Shire expects the 3 additional dosage strengths of 20, 40, and 60 mg will be available in retail pharmacies in the second quarter of 2008 to supplement the existing 30-, 50-, and 70-mg dosage strengths currently available. These additional dosage strengths will allow for more gradual titration of the medication and will be instrumental in helping physicians modify patients' treatment plans.

Dosage Form:
Tablets: 20, 30, 40, 50, 60, and 70 mg

For More Information:
www.vyvanse.com



Welchol


Marketed by:
Daiichi Sankyo Inc (Parsippany, NJ)

Indication:
January 18, 2008—Daiichi Sankyo Inc announced that the FDA approved an additional indication for Welchol (colesevelam HCl) to improve glycemic control (measured as hemoglobin A1C) in adults with type 2 diabetes mellitus in combination with metformin, sulfonylureas, or insulin, either alone or in combination with other antidiabetic agents. Since 2000,Welchol has been marketed for the reduction of low-density lipoprotein (LDL) cholesterol levels.Welchol is now the first and only medication approved to reduce both glucose levels and LDL cholesterol levels (as an adjunct to diet and exercise).

Dosage Form:
Tablets: 625 mg

For More Information:
www.Welchol.com
877-4-DSPROD (877-431-7763)