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
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)
