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Cialis
Marketed by:
Eli Lilly and Co (Indianapolis, IN)
Indication:
January 8, 2008?Eli Lilly and Co announced that the FDA approved Cialis (tadalafil) for oncedaily use (2.5 and 5 mg), an oral medication taken once per day to treat erectile dysfunction (ED), which is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. When Cialis for oncedaily use is taken daily, men can attempt sexual activity at any time between doses. This low-dose daily treatment option may be most appropriate for men with ED who anticipate more frequent sexual activity (eg, twice weekly). For other men, Cialis taken as needed (the previously approved dosing regimen) may be most appropriate.
Dosage Form:
Tablets: 2.5, 5, 10, and 20 mg
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HUMIRA
Marketed by:
Abbott Laboratories (Abbott Park, IL)
Indication:
February 22, 2008?Abbott Laboratories announced that it received FDA approval to market HUMIRA (adalimumab) as a treatment to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients 4 years of age and older?the sixth indication for the drug since its original approval in 2002. HUMIRA is the first biologic to be approved by the FDA for this condition since 1999, and it is the first to be administered by injection in these patients once every 2 weeks. JIA patients who weigh 30 kg (66 lb) or more will use the same 40-mg HUMIRA pen or prefilled syringe currently used by adult patients. Children who weigh at least 15 kg (33 lb) but < 30 kg will receive HUMIRA via a 20-mg prefilled syringe manufactured exclusively for JIA patients.
Dosage Form:
40 mg/0.8 mL in a single-use prefilled pen (HUMIRA pen); 40 mg/0.8 mL in a single-dose prefilled glass syringe; 20 mg/0.4 mL in a single-dose prefilled glass syringe
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NovoLog
Marketed by:
Novo Nordisk (Princeton, NJ)
Indication:
March 18, 2008?Novo Nordisk announced that the FDA approved NovoLog (insulin aspart [rDNA origin] injection) for continuous subcutaneous insulin infusion by external insulin pump in pediatric patients between the ages of 4 and 18 years. NovoLog is the first and only insulin analogue approved for this use. It is indicated to improve glycemic control in adults and children with diabetes mellitus, and an injection should be immediately followed by a meal. NovoLog has a more rapid onset and shorter duration of action than regular human insulin. Because of the shorter duration of action, a longer-acting insulin also should be used in patients with type 1 diabetes and may also be needed in patients with type 2 diabetes.
Dosage Form:
100 units/mL of insulin aspart in each of the following presentations: 10-mL vials; 3-mL Pen-Fill cartridges; 3-mL NovoLog Mix 70/30 FlexPen Prefilled Syringe
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Glumetza
Marketed by:
Depomed Inc (Menlo Park, CA)
Indication:
January 2, 2008?Depomed Inc announced that the FDA approved the 1000-mg strength tablets of Glumetza (metformin hydrochloride extendedrelease). Glumetza is indicated alone or in combination with a sulfonylurea or insulin as an adjunct to diet and exercise to improve glycemic control in adult patients (aged 18 years and older) with type 2 diabetes. These patients now have 2 ways to achieve 24-hour glycemic control: the original Glumetza 500-mg tablets, which start as small, easy-to-swallow tablets that expand once in the stomach; and the new 1000-mg tablets, which require fewer tablets to reach the target dose.
Dosage Form:
Tablets: 500 and 1000 mg
For More Information:
www.glumetzaxr.com
Orencia
Marketed by:
Bristol-Myers Squibb Co (Princeton, NJ)
Indication:
April 8, 2008?Bristol-Myers Squibb Co announced that the FDA approved Orencia (abatacept) for reducing signs and symptoms in pediatric patients aged 6 years and older with moderately to severely active polyarticular juvenile idiopathic arthritis. Orencia may be used as monotherapy or concomitantly with methotrexate. Orencia should not be administered concomitantly with tumor necrosis factor antagonists and is not recommended for use concomitantly with other biologic rheumatoid arthritis therapy, such as anakinra.
Dosage Form:
250-mg single-use vial
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Hot Rx
Rotarix
Marketed by:
GlaxoSmithKline (Philadelphia, PA)
Indication:
April 3, 2008?GlaxoSmithKline announced that the FDA approved Rotarix (rotavirus vaccine, live, oral) for the prevention of rotavirus gastroenteritis in infants. Rotarix will offer protection against the most commonly circulating rotavirus types in the United States and will allow infants to complete the vaccination series by 4 months of age. The Centers for Disease Control and Prevention currently recommends that children complete the rotavirus immunization series by 6 months of age. Rotavirus is the leading cause of severe gastroenteritis in infants and young children in the United States.
Dosage Form:
Solvent (1 mL) in glass prefilled syringe (for oral use only); vaccination course consists of 2 doses?the first dose should be given between 6 and 14 weeks of age, and the second dose between 14 and 24 weeks of age, with the interval between the doses not less than 4 weeks
For More Information:
www.gsk.com
Omnitrope
Marketed by:
Sandoz (Princeton, NJ)
Indication:
March 12, 2008?Sandoz announced the introduction of Omnitrope Pen 5 with liquid cartridge, a new form of the first follow-on version of a previously approved recombinant biotechnology drug approved by the FDA. Omnitrope is a somatropin (rDNA origin) for injection recombinant and is approved for long-term treatment of pediatric patients who have growth failure and long-term replacement therapy in adults with growth hormone deficiency. This new delivery system is convenient for patients because the liquid is already dissolved in a ready-touse cartridge and can be loaded into the pen for injection. According to the FDA, Omnitrope is highly similar to Genotropin, the comparator reference product, in its pharmacokinetic/pharmacodynamic, safety, and efficacy profiles.
Dosage Form:
5 mg
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Opana ER
Marketed by:
Endo Pharmaceuticals Inc (Chadds Ford, PA)
Indication:
March 3, 2008?Endo Pharmaceuticals Inc, a whollyowned subsidiary of Endo Pharmaceuticals Holdings Inc, announced that the FDA approved 3 new dosage strengths?7.5, 15, and 30 mg?of Opana (oxymorphone hydrochloride) extended-release (ER) tablets CII. Opana ER, an opioid analgesic, is indicated for the relief of moderate-to-severe pain in patients requiring continuous opioid treatment for an extended period of time. The 3 new dosage strengths will allow physicians to more easily titrate patients to the optimal level of pain relief. The product contains oxymorphone, which is a morphine-like opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics.
Dosage Form:
Tablets: 5, 7.5, 10, 15, 20, 30, and 40 mg
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