- Resource Centers
Azilect (rasagiline tablets)
Marketed by: Teva Pharmaceutical Industries (Jerusalem, Israel)
Indication: May 17, 2006?Teva Pharmaceutical Industries announced that the FDA granted approval for once-daily Azilect (rasagiline tablets). Azilect is indicated as a treatment for Parkinson's disease, both as initial monotherapy in patients with early Parkinson's disease and as adjunct therapy to levodopa in moderate-to-advanced stages of the disease.
Dosage Form: Tablets: 0.5 and 1 mg
For More Information: www.tevapharm.com
Lumigan (bimatoprost ophthalmic solution) 0.03%
Marketed by: Allergan Inc (Irvine, Calif)
Indication: June 23, 2006?Allergan announced that the FDA approved Lumigan, its once-daily prescription eye drop. Lumigan is now approved as a first-line treatment for elevated intraocular pressure associated with open-angle glaucoma or ocular hypertension, in addition to a second-line treatment.
Dosage Form: 2.5-mL fill in 5-mL container, 5-mL fill in 10-mL container, and 7.5-mL fill in 10-mL container
For More Information: www.allergan.com
Opana ER (oxymorphone hydrochloride extended-release tablets)
Marketed by: Endo Pharmaceuticals Inc (Chadds Ford, Pa)
Indication: June 23, 2006?The FDA granted final approval for Endo Pharmaceuticals'New Drug Application for Opana ER, an extended-release formulation of oxymorphone hydrochloride. This extended-release opioid analgesic is indicated for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended length of time, and it is not intended to be used on an as-needed basis. Endo is partnering with Penwest Pharmaceuticals Co in the development and commercialization of the product.
Dosage Form: Tablets: 5, 10, 20, and 40 mg
For More Information: www.opana.com
Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets)
Marketed by: BioMarin Pharmaceutical Inc (Novato, Calif) and Alliant Pharmaceuticals Inc (Alpharetta, Ga)
Indication: June 1, 2006?The FDA granted marketing approval for Orapred ODT, the first orally disintegrating tablet form of prednisolone available in the United States. Orapred ODT is prescribed primarily for acute exacerbations of asthma in children.
Dosage Form: Tablets: Equivalent to prednisolone 15 mg/5 mL
For More Information: www.bmrn.com
Marketed by: Tibotec Therapeutics, a division of Ortho Biotech Products, LP (Bridgewater, NJ), a wholly owned subsidiary of Johnson & Johnson
Indication: June 23, 2006?The FDA granted accelerated approval for Prezista, a new drug for the treatment of HIV. Prezista, a protease inhibitor, is to be coadministered with a low dose of ritonavir and other anti-HIV agents. Ritonavir slows the breakdown of Prezista, thereby increasing its concentration in the patient's system.
Dosage Form: Tablets: 300 mg
For More Information: www.jnj.com
Marketed by: Celgene Corp (Summit, NJ)
Indication: June 29, 2006?The FDA granted approval for Celgene's Supplemental New Drug Application for an additional indication for Revlimid?for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy. It also is approved for use in the treatment of patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
Dosage Form: Capsules: 5, 10, 15, and 25 mg
For More Information: www.revlimid.com
Marketed by: Bristol-Myers Squibb Co (Princeton, NJ)
Indication: June 28, 2006?Bristol-Myers Squibb announced that the FDA granted accelerated approval of Sprycel, an oral inhibitor of multiple tyrosine kinases. Sprycel is indicated for the treatment of adults in all phases of chronic myeloid leukemia with resistance or intolerance to prior therapy, including Gleevec (imatinib mesylate). Additionally, the FDA granted full approval of Sprycel for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy.
Dosage Form: Tablets: 20, 50, and 70 mg
For More Information: www.bms.com
Marketed by: Celgene Corp (Summit, NJ)
Indication: May 25, 2006?The FDA announced approval of Thalomid for the treatment of newly diagnosed multiple myeloma, which are cancers that affect bone marrow cells important in fighting infection. The drug is to be used in conjunction with dexamethasone, a standard chemotherapy treatment.
Dosage Form: Capsules: 50, 100, and 200 mg
For More Information: www.thalomid.com
Zelapar (selegiline HCl)
Marketed by: Valeant Pharmaceuticals International (Costa Mesa, Calif)
Indication: June 15, 2006?The FDA approved a monoamine oxidase- B inhibitor, Zelapar?a once-daily adjunct therapy for patients with Parkinson's disease being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. Zelapar is the first Parkinson's disease treatment to use a novel oral delivery system which allows the tablets to dissolve within seconds in the mouth.
Dosage Form: Tablets: 1.25 mg
For More Information: www.zelapar.com
Gardasil (quadrivalent human papillomavirus [types 6, 11, 16, 18] recombinant vaccine)
Marketed by: Merck & Co Inc (Whitehouse Station, NJ)
Indication: June 8, 2006?The FDA announced approval of Gardasil (Quadrivalent Human Papillomavirus [HPV] [Types 6, 11, 16, 18] Recombinant Vaccine), the first and only vaccine to prevent cervical cancer and vulvar and vaginal precancers caused by HPV types 16 and 18 and to prevent low-grade and precancerous lesions and genital warts caused by HPV types 6, 11, 16, and 18. The product also is approved for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16, and 18. Gardasil is approved for 9-to 26-year-old girls and women.
Dosage Form: Intramuscular administration: three 0.5-mL doses?first dose at elected date; second dose 2 months after first dose; third dose 6 months after first dose
For More Information: www.gardasil.com