First-Time Generic Approvals: Oral Zofran, Wellbutrin XL, Kefzol Bulk Packages

Yael Waknine

January 05, 2007

January 5, 2007 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for ondasetron tablets, orally disintegrating tablets, and oral solution for the prophylaxis of nausea and vomiting; bupropion HCl extended-release tablets for the treatment of major depressive disorder; and cefazolin sodium injection in pharmacy bulk packages for the treatment and prophylaxis of certain infections.


Generic Oral Ondasetron (Zofran) for Antiemetic Use

On December 27, the FDA approved first-time generic formulations for ondasetron HCl 4-, 8-, 16-, and 24-mg tablets (made by Dr. Reddy Laboratories, Ltd); 4-, 8-, 16-, and 24-mg orally disintegrating tablets (made by Kali Laboratories, Inc); and 4-mg/5-mL oral solution (made by Roxane Laboratories, Inc; brand name Zofran, all brand formulations made by GlaxoSmithKline).

Ondasetron was the 20th highest-selling brand-name drug in the United States in 2005, with sales totaling $839,256,543 as reported in the online magazine Drug Topics. Approval of the generic formulation is therefore economically significant, according to the FDA.

Oral ondasetron is indicated for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin; nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy; nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen; and for the prevention of postoperative nausea and/or vomiting.

As with other antiemetics, routine prophylaxis is not recommended for patients at low risk for postoperative nausea and vomiting. However, oral ondasetron therapy is recommended for low-risk patients for whom nausea and vomiting must be avoided postoperatively

First-time generic formulations for ondasetron 2-mg/mL injection packaged in single (4 mg/2 mL) and multidose (40 mg/20 mL) vials (made by Teva Pharmaceuticals USA) previously were approved on November 22, 2006, for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy and the prevention of postoperative nausea/vomiting.


Generic Bupropion Extended-Release (Wellbutrin XL) for Depression

On December 14, the FDA approved first-time generic formulations for bupropion HCl 150- and 300-mg extended-release tablets (made by Anchen Pharmaceuticals, Inc; brand name Wellbutrin XL, made by GlaxoSmithKline).

Wellbutrin XL was the 21st highest-selling brand-name drug in the United States during 2005, with sales totaling $1,326,323,000 as reported in the online magazine Drug Topics. Approval of the generic formulation is therefore economically significant, according to the FDA.

Prior to the approval, the FDA considered a citizen petition regarding several issues for generic bupropion, including potential disparities between the generic's and brand's absorption into the bloodstream. After reviewing these concerns, the agency determined that its standards for approval of the generic drug application for bupropion were appropriate.

Bupropion extended-release tablets are indicated for the treatment of major depressive disorder.


Cefazolin Sodium Injection in Bulk Packages (Kefzol) for Antibiotic Use

On November 29, the FDA approved generic formulations for cefazolin sodium injection in 100- and 300-g pharmacy bulk packages (made by Samson Medical Technologies, LLC; brand name Kefzol, discontinued by Eli Lilly & Co, Inc).

Cefazolin injection is indicated for the treatment of respiratory tract infections, urinary tract infections, skin/skin structure infections, biliary tract infections, bone and joint infections, and genital infections; septicemia; and endocarditis caused by susceptible microorganisms. It is also indicated for the prophylaxis of certain postoperative infections in high-risk patients.

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