rx PRODUCT news

Pharmacy Times, Volume 0, 0

Aptivus

Marketed by:

Boehringer IngelheimPharmaceuticals Inc(Ridgefield, CT)

Indication:

October 5, 2007—BoehringerIngelheim Pharmaceuticals Incannounced that it received full (traditional)FDA approval of Aptivus(tipranavir) capsules. The FDAgranted accelerated approval toAptivus in June 2005; acceleratedapproval is a regulatory processthat expedites the approval of therapies for serious orlife-threatening illnesses. Aptivus, a protease inhibitor,co-administered with 200 mg of ritonavir (Aptivus/r), isindicated for combination antiretroviral treatment ofHIV-1?infected adult patients who are treatment-experiencedand infected with HIV-1 strains resistant to >1protease inhibitor. The use of Aptivus in treatmentna?vepatients 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—TaroPharmaceutical Industries Ltdreported that its US affiliate, TaroPharmaceuticals USA Inc, receivedFDA approval for its new drug application for Flo-Pred(prednisolone acetate oral suspension) equivalent to 5mg/5 mL and 15 mg/5 mL prednisolone in Taro'spatent-protected NonSpil liquid drug delivery system.Flo-Pred is an anti-inflammatory agent for the treatmentof asthma, certain allergic and dermatologicconditions, as well as a variety of other indications.Flo-Pred does not require refrigeration and does notrequire shaking prior to use. The patent-protected,taste-masking formula has a cherry flavor, which maybe 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 ofOrtho Biotech Products LP(Bridgewater, NJ)

Indication:

January 18, 2008—The FDA hasgranted accelerated approval toINTELENCE (etravirine) tablets.INTELENCE, in combination withother antiretroviral agents, is indicatedfor the treatment of HIV-1 inantiretroviral treatment-experiencedadult patients who have evidence of viral replicationand HIV-1 strains resistant to a nonnucleosidereverse transcriptase inhibitor (NNRTI) and other antiretroviralagents. INTELENCE is the first new NNRTI tobe introduced in nearly 10 years. NNRTIs blockreverse transcriptase, a key enzyme that HIV uses toreplicate.

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 Increceived FDA approval of the SymlinPen 120 and theSymlinPen 60 pen-injector devices for administeringSYMLIN (pramlintide acetate) injection. These newprefilled pen-injector devices feature simple, fixeddosing to improve mealtime glucose control.SymlinPen 60 features fixed dosing to deliver 15, 30,45, or 60 mcg/dose. SymlinPen 120 features fixed dosingto deliver 60 or 120 mcg/dose. Both pen-injectordevices can be conveniently stored at room temperaturenot to exceed 86?F (30?C) after first use. SYMLINis an antihyperglycemic drug given at mealtimes foruse in patients with diabetes treated with insulin.

Dosage Form:

SymlinPen 60: 15, 30, 45, or 60 mcg/dose; SymlinPen120: 60 or 120 mcg/dose

For More Information:

www.symlin.com

800-349-8919

Hot Rx

AmniScreenHome DetectionLiner Kit

Marketed by:

DuramedPharmaceuticals Inc(Pomona, NY),a subsidiary of BarrPharmaceuticals Inc

Indication:

January 28, 2008—The AmniScreen Home DetectionLiner Kit, from Duramed Pharmaceuticals, was FDAapproved as an at-home test to be used as an aidfor detecting amniotic fluid leakage in pregnantwomen experiencing unexplained vaginal wetness.The kit, available by prescription only, contains 3testing panty liners (TPL) and 3 drying trays. The TPLis a regular panty liner with an indicator strip assembledinto the panty liner, covered with 2 layers of a1-way perforated film. The kit is intended to detectpossible leakage of amniotic fluid by indicating pHlevel (amniotic fluid normally has pH levels of 6.5-7.5units). If pH levels are ≥5.2, the TPL will produce ablue?green color. Patients are instructed to report orshow test results to their health care provider forinterpretation 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 PharmaceuticalsCorp(East Hanover, NJ)

Indication:

January 21, 2008—Tekturna HCT (aliskirenand hydrochlorothiazide) was FDA approved as a single-tablet combination of 2 high blood pressure medicines:Tekturna (aliskiren), the first new type of highblood pressure medicine in more than a decade, andthe diuretic hydrochlorothiazide (HCT). The 2 medicinesin this single-tablet combination work togetherto lower blood pressure, with clinical data showingthat the combination of Tekturna and HCT offersgreater blood pressure reductions than either componentalone. Tekturna HCT is approved for patients notcontrolled by either medicine alone but should not beused 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 plcannounced that it received FDAapproval for 3 additional dosagestrengths for Vyvanse (lisdexamfetaminedimesylate).Vyvanse is indicated for thetreatment of attention-deficit/hyperactivity disorder.Shire expects the 3 additional dosage strengths of 20,40, and 60 mg will be available in retail pharmacies inthe second quarter of 2008 to supplement the existing30-, 50-, and 70-mg dosage strengths currentlyavailable. These additional dosage strengths will allowfor more gradual titration of the medication and willbe 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 SankyoInc announced that the FDAapproved an additional indicationfor Welchol (colesevelam HCl) toimprove glycemic control (measured as hemoglobinA1C) in adults with type 2 diabetes mellitus in combinationwith metformin, sulfonylureas, or insulin, eitheralone or in combination with other antidiabeticagents. Since 2000,Welchol has been marketed forthe reduction of low-density lipoprotein (LDL) cholesterollevels.Welchol is now the first and only medicationapproved to reduce both glucose levels and LDLcholesterol 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)