Generic Product News
Marketed by:
E. Fougera & Co (Melville, NY), a division of Nycomed US Inc
Compared to:
Aldara (Graceway Pharmaceuticals)
Indication:
E. Fougera & Co announced that it received first generic approval from the FDA for Imiquimod Cream 5%, Imiquimod Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults; biopsy-confirmed, primary superficial basal cell carcinoma in immunocompetent adults—maximum tumor diameter of 2.0 cm on trunk, neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured; and external genital and perianal warts/ condyloma acuminata in patients 12 years of age or older.
Dosage Form:
Imiquimod Cream 5% is supplied in a box containing 24 single-use packets, each of which contains 250 mg of the cream, equivalent to 12.5 mg of imiquimod.
For More Information:
www.fougera.com
800-645-9833
PANCRELIPASE Delayed-release Capsules
Marketed by:
X-GEN Pharmaceuticals Inc (Big Flats, NY)
Compared to:
Zenpep (pancrelipase) delayed-release capsules
Indication:
X-GEN Specialty Division announced that it entered into a distribution agreement with Eurand Pharmaceuticals Inc for an authorized generic to the company’s FDA-approved pancreatic enzyme product ZENPEP (pancrelipase) delayed-release capsules, a product developed to meet the 2004 pancreatic enzyme product guidelines and regulations, approved by the FDA in August 2009. In accordance with the agreement, X-GEN will distribute PANCRELIPASE (pancrelipase) delayed-release capsules, the authorized generic to the low-dosage strength of ZENPEP. Dosage Form: PANCRELIPASE capsules are orally administered and contain delayed-release beads of porcine pancreatic enzyme concentrate consisting of lipase (5000 USP units), amylase (27,000 USP units), and protease (17,000 USP units).
For More Information:
www.x-gen.us
607-562-2700
(Note: PANCRELIPASE capsules are not available in 4 strengths as noted in the March 2010 issue. The correct dosage form is listed here.)
Marketed by:
Teva Pharmaceuticals (North Wales, PA)
Compared to:
Trusopt Sterile Ophthalmic Solution (Merck & Co Inc)
Indication:
Teva Pharmaceuticals announced the introduction and availability of Dorzolamide Hydrochloride Ophthalmic Solution, 2%. This product is AT-rated and bioequivalent to Trusopt Sterile Ophthalmic Solution. The product is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Dorzolamide HCl Ophthalmic Solution is available in 2% strength, in a 10-mL bottle size.
Dosage Form:
The dose is 1 drop of dorzolamide HCl ophthalmic solution, 2%, in the affected eye(s) 3 times daily.
For More Information:
www.tevausa.com
888-TEVA USA (888-838-2872)
Ursodiol Capsules
Marketed by:
Mylan Inc (Pittsburgh, PA)
Compared to:
Actigall (Watson Pharma Inc)
Indication:
Mylan Inc announced that its subsidiary, Mylan Pharmaceuticals Inc, received final approval from the FDA for its abbreviated new drug application for Ursodiol Capsules USP, 300 mg. Ursodiol capsules are indicated for patients with radiolucent, noncalcified gallbladder stones <20 mm in greatest diameter in whom selective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those individuals who refuse surgery; also for the prevention of gallstone formation in obese patients experiencing rapid weight loss.
Dosage Form:
Capsules: 300 mg
For More Information:
www.mylan.com â–
