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Gilenya
Marketed by:
Novartis Corporation (East Hanover, NJ)
Indication:
Novartis has announced that the FDA approved Gilenya (fingolimod) capsules as the first oral disease-modifying therapy for relapsingremitting multiple sclerosis (MS). Gilenya is one of a new class of drugs that blocks blood cells in the lymph nodes, reducing their migration to the brain and spinal cord, which may help in reducing the severity of MS. Before Gilenya, only injectable options were available for patients with MS. Patients taking Gilenya should be monitored for bradycardia, increased risk of infections, and macular edema.
Dosage Form:
Capsules: 0.5 mg
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Krystexxa
Marketed by:
Savient Pharmaceuticals, Inc (East Brunswick, NJ)
Indication:
Savient has announced the FDA approval of Krystexxa (pegloticase) injection for the treatment of chronic gout in adult patients not responding to conventional therapy. Krystexxa is a pegylated uric acid—specific enzyme with a recommended dose for adult patients of 8 mg every 2 weeks by intravenous infusion. Patients can expect to experience clinical improvement within 6 months. Krystexxa should be dispensed with a corticosteroid and an antihistamine to decrease the risk of allergic reactions. Caution should be used in patients with congestive heart failure. In association with the FDA, Savient has created a Risk Evaluation and Mitigation Strategy program to facilitate a communication plan for health care providers and provide a medication guide for patients.
Dosage Form:
Single-use vials containing 8 mg/mL of pegloticase protein for dilution
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ella
Marketed by:
Watson Pharmaceuticals (Morristown, NJ)
Indication:
The FDA has approved ella (ulipristal acetate), a new emergency contraception pill that can be taken within 5 days after unprotected sexual intercourse or contraceptive failure. The FDA stresses that ella is not intended for routine use as a contraceptive. Ella is a progesterone antagonist-agonist that works by inhibiting or delaying ovulation. Women with a known or suspected pregnancy or women who are breast-feeding should not take ella. Unlike levonorgestrel, the other FDA-approved emergency contraceptive, ella will be available by prescription only and should be available by the end of 2010.
Dosage Form:
Tablets: 30 mg
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Beyaz
Marketed by:
Bayer Healthcare Pharmaceuticals (Wayne, NJ)
Indication:
The FDA approved Beyaz, a new oral contraceptive that combines drospirenone and ethinyl estradiol with Metafolin (levomefolate calcium), a stable form of the naturally occurring folate. Beyaz is indicated for the prevention of pregnancy; the treatment of premenstrual dysphoric disorder for women who choose oral contraceptives to prevent pregnancy; and the treatment of moderate acne in women 14 years of age or older only if the patient chooses oral contraceptives for birth control. Beyaz is also approved for raising folate levels in women who choose oral contraception and want to reduce the risk of neural tube defects in a pregnancy conceived during or shortly after discontinuing the product.
Dosage Form:
Tablets: 24 days of 3 mg drospirenone, 0.20 mg ethinyl estradiol, and 0.451 mg levomefolate calcium, followed by 4 days of 0.451 mg levomefolate calcium only
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Faslodex
Marketed by:
AstraZeneca (Wilmington, DE)
Indication:
AstraZeneca announced the FDA approval of the 500-mg dose of Faslodex (fulvestrant) injection, replacing the monthly dose of 250 mg, for the treatment of hormone receptor—positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy. Faslodex will now be administered intramuscularly into the buttocks as two 250-mg injections, one in each buttock, on days 1, 15, and 29, and once monthly thereafter. Two 250-mg vials will be packaged together beginning at the end of 2010. Until then, the 250-mg single dose will still be available.
Dosage Form:
Two 5-mL barrels, each containing 250 mg/5 mL fulvestrant for intramuscular use
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Suboxone Film
Marketed by:
Reckitt Benckiser Pharmaceuticals Inc (Richmond, VA)
Indication:
Reckitt Benckiser announced the FDA approval of Suboxone (buprenorphine and naloxone) Sublingual Film, a new formulation designed to improve compliance in patients being treated for opioid dependence. Suboxone film is indicated for maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. The dosage of Suboxone Film should be titrated to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms. The recommended daily dose for maintenance is 16/4 mg buprenorphine/ naloxone.
Dosage Form:
Sublingual Film: 2/0.5 mg, 8/2 mg buprenorphine/naloxone
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Taxotere
Marketed by:
sanofi-aventis (Bridgewater, NJ)
Indication:
Sanofi-aventis announced a new 1-vial formulation of Taxotere (docetaxel), a chemotherapeutic agent FDA-approved for use in treating patients at specific stages of breast cancer, androgen-independent prostate cancer, advanced nonsmall cell lung cancer, advanced gastric adenocarcinoma, and locally advanced squamous cell carcinoma of the head and neck. Previously, Taxotere was only available in a 2-vial formulation, with 1 vial containing docetaxel concentrate and the other containing diluent. The new 1-vial Taxotere can be added directly into the infusion solution, which simplifies preparation by eliminating the dilution step. Ingredients and intravenous infusion administration remain the same.
Dosage Form:
Single-use vials containing 80 mg/4 mL (20 mg/mL) of docetaxel concentrate
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Butrans Transdermal System CIII
Marketed by:
Purdue Pharma LP (Stamford, CT)
Indication:
The FDA approved Butrans (buprenorphine) Transdermal System CIII, which is indicated for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time. One transdermal patch will deliver a continuous release of medication for 7 days. Butrans is expected to launch in early 2011. The risk of QTc interval prolongation increases dramatically with higher strengths, so doses greater than 20 mcg/hour are not recommended. Because Butrans has the potential for abuse similar to other opioids, Purdue, in conjunction with the FDA, has developed a Risk Evaluation and Mitigation Strategy program to provide health care providers with pertinent information.
Dosage Form:
Transdermal patch: 5, 10, and 20 mcg/hour
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