generic times product news

NOVEMBER 01, 2006

Alprazolam Extended-release Tablets

Marketed by: Barr Laboratories Inc (Woodcliff Lake, NJ), a subsidiary of Barr Pharmaceuticals Inc

Compared to: Xanax XR (Pfizer Inc)

Indication: August 1, 2006—Barr announced that it received final approval from the FDA for its application to manufacture and market alprazolam extended-release tablets, 0.5, 1, 2, and 3 mg. These tablets are indicated for the treatment of panic disorder, with or without agoraphobia.

Dosage Form: Tablets: 0.5, 1, 2, and 3 mg

For More Information: 800-BARRLAB (800-227-7522)

Furosemide Tablets

Marketed by: Ranbaxy Laboratories Ltd (Guragon, India)

Compared to: Lasix Tablets (Aventis Pharmaceuticals Inc)

Indication: September 21, 2006—The FDA granted approval to Ranbaxy to manufacture and market furosemide tablets, USP, 20, 40, and 80 mg. The FDA has determined them to be bioequivalent and to have the same therapeutic effect as the reference drug, Lasix. These tablets are indicated in adults, infants, and children for the treatment of edema with congestive heart failure, liver cirrhosis, and renal disease.

Dosage Form: Tablets: 20, 40, and 80 mg

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Simvastatin Tablets

Marketed by: Teva Pharmaceuticals (North Wales, Pa)

Compared to: Zocor (Merck & Co Inc)

Indication: June 27, 2006—Teva Pharmaceuticals announced the introduction and availability of simvastatin tablets, which are AB-rated and bioequivalent to Zocor tablets. These tablets are indicated to reduce elevated total cholesterol, low-density lipoprotein cholesterol, Apo B, and triglycerides, and to increase high-density lipoprotein cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia.

Dosage Form: Tablets: 5, 10, 20, and 40 mg

For More Information: 888-TEVA-USA (838-2872)

Topiramate Tablets

Marketed by: Mylan Laboratories (Pittsburgh, Pa)

Compared to: Topamax (Ortho-McNeil)

Indication: September 12, 2006—Mylan Laboratories announced that it received final approval from the FDA for topiramate tablets, 25, 100, and 200 mg. Topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial-onset or primary generalized tonic-clonic seizures.

Dosage Form: Tablets: 25, 100, and 200 mg

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Triamcinolone Acetonide Ointment

Marketed by: Perrigo Co (Allegan, Mich)

Indication: September 13, 2006—Perrigo Co announced it will launch triamcinolone acetonide ointment with a new Perrigo brand design and new national drug code (NDC) numbers for 2 strengths. The NDC number for triamcinolone acetonide ointment 0.025%, 80 g, was 0414- 0054-36 and is now 45802-054-36, and the NDC number for triamcinolone acetonide ointment 0.1%, 1 lb, was 0414-0055-05 and is now 45802-055-05. The product is a topical cortico-steroid used for the relief of the inflammatory 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

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