generic times product news
Alprazolam Extended-release Tablets
Marketed by:Barr Laboratories Inc(Woodcliff Lake, NJ), asubsidiary of Barr Pharmaceuticals Inc
Compared to:Xanax XR (Pfizer Inc)
Indication:August 1, 2006—Barr announced that it received finalapproval from the FDA for its application to manufactureand market alprazolam extended-release tablets,0.5, 1, 2, and 3 mg. These tablets are indicated for thetreatment of panic disorder, with or without agoraphobia.
Dosage Form:Tablets: 0.5, 1, 2, and 3 mg
For More Information:www.barrlabs.com800-BARRLAB (800-227-7522)
Marketed by:Ranbaxy Laboratories Ltd(Guragon, India)
Compared to:Lasix Tablets (AventisPharmaceuticals Inc)
Indication:September 21, 2006—The FDA granted approval toRanbaxy to manufacture and market furosemidetablets, USP, 20, 40, and 80 mg. The FDA has determinedthem to be bioequivalent and to have thesame therapeutic effect as the reference drug, Lasix.These tablets are indicated in adults, infants, and childrenfor the treatment of edema with congestiveheart failure, liver cirrhosis, and renal disease.
Dosage Form:Tablets: 20, 40, and 80 mg
For More Information:www.ranbaxy.com
Marketed by:TevaPharmaceuticals(North Wales, Pa)
Compared to:Zocor (Merck & Co Inc)
Indication:June 27, 2006—Teva Pharmaceuticals announced theintroduction and availability of simvastatin tablets,which are AB-rated and bioequivalent to Zocor tablets.These tablets are indicated to reduce elevated totalcholesterol, low-density lipoprotein cholesterol, Apo B,and triglycerides, and to increase high-density lipoproteincholesterol in patients with primary hypercholesterolemiaand mixed dyslipidemia.
Dosage Form:Tablets: 5, 10, 20, and 40 mg
For More Information:www.tevausa.com888-TEVA-USA (838-2872)
Marketed by:Mylan Laboratories (Pittsburgh, Pa)
Compared to:Topamax (Ortho-McNeil)
Indication:September 12, 2006—Mylan Laboratories announcedthat it received final approval from the FDA for topiramatetablets, 25, 100, and 200 mg. Topiramate tabletsare indicated as initial monotherapy in patients 10years of age and older with partial-onset or primarygeneralized tonic-clonic seizures.
Dosage Form:Tablets: 25, 100, and 200 mg
For More Information:www.mylan.com
Triamcinolone Acetonide Ointment
Marketed by:Perrigo Co (Allegan, Mich)
Indication:September 13, 2006—Perrigo Co announced it willlaunch triamcinolone acetonide ointment with a newPerrigo brand design and new national drug code (NDC)numbers for 2 strengths. The NDC number for triamcinoloneacetonide ointment 0.025%, 80 g, was 0414-0054-36 and is now 45802-054-36, and the NDC numberfor triamcinolone acetonide ointment 0.1%, 1 lb,was 0414-0055-05 and is now 45802-055-05. The productis a topical cortico-steroid used for the relief of theinflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage Form:Ointment: 0.025%, 15-, 80-, and 454-g tubes; 0.1%, 15-,80-, and 454-g tubes; 0.5%, 15-g tubes
For More Information:www.perrigo.com