PRODUCT news

Published Online: Friday, August 1, 2008

Budeprion Hydrochloride Extended-release Tablets


Marketed by:
Teva Pharmaceuticals (North Wales, PA)
Compared to:
Wellbutrin XL (GlaxoSmithKline)

Indication:
May 30, 2008—Teva Pharmaceuticals announced the introduction and availability of Budeprion XL (bupropion hydrochloride extended-release tablets USP [XL]), 150 mg. The product is AB-rated and bioequivalent to Wellbutrin XL tablets. Budeprion XL, an antidepressant of the aminoketone class, is indicated for the treatment of major depressive disorder. A major depressive episode implies the presence of depressed mood or loss of interest or pleasure. With the addition of this new strength, Teva now offers the tablets in 150- and 300-mg strengths, in bottle sizes of 30 and 500. All patients being treated with antidepressants for any indication should be monitored and observed for clinical worsening, suicidality, and unusual behavior, especially during the initial few months of therapy or at times of dose changes.

Dosage Form:
Tablets: 150 and 300 mg
For More Information:
www.tevausa.com
888-TEVA USA (888-838-2872)


Cetirizine Hydrochloride Syrup, 1 mg/mL


Marketed by:
Perrigo Co (Allegan, MI)
Compared to:
Zyrtec Syrup (McNeil Consumer Healthcare)

Indication:
June 19, 2008—Perrigo Co announced that it received FDA approval to manufacture and market Cetirizine Hydrochloride Syrup (Rx only), 1 mg/mL. The product is indicated for the relief of symptoms associated with seasonal allergic rhinitis, and it is comparable to McNeil Consumer Healthcare's Zyrtec Syrup, 1 mg/mL. This product will add to Perrigo's already existing line of Cetirizine tablets, Cetirizine D, and Cetirizine OTC syrup.

Dosage Form:
Syrup: 1 mg/mL
For More Information:
www.perrigo.com


Dronabinol


Marketed by:
Par Pharmaceutical Companies Inc (Woodcliff Lake, NJ)
Compared to:
Marinol (Solvay Pharmaceuticals)

Indication:
June 30, 2008—Par Pharmaceutical Companies announced that it received approval from the FDA for its Abbreviated New Drug Application for dronabinol, a generic version of Solvay Pharmaceuticals' Marinol, a CIII controlled substance. This product is approved to treat nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Dronabinol is contraindicated in any patient who has a history of hypersensitivity to any cannabinoid, sesame oil, or any ingredients in dronabinol capsules. Warn patients not to drive, operate machinery, or engage in hazardous activity until they establish that they can tolerate dronabinol and perform such tasks.

Dosage Form:
Capsules: 2.5, 5, and 10 mg
For More Information:
www.parpharm.com


Rifampin


Marketed by:
Lannett Co Inc (Philadelphia, PA)
Compared to:
Rifadin Capsules (sanofi-aventis US LLC)

Indication:
March 31, 2008— Lannett Co Inc, a manufacturer of generic pharmaceuticals, announced that it received FDA approval for its Abbreviated New Drug Application for Rifampin capsules in 150- and 300-mg strengths. Rifampin is indicated in the treatment of all forms of tuberculosis and for the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx.

Dosage Form:
Capsules: 150 and 300 mg
For More Information:
www.lannett.com



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