First-Time Generic Approvals: Ditropan XL, Zofran Injection/Premixed Injection, Oxandrin

Yael Waknine

December 17, 2006

December 15, 2006 -- The US Food and Drug Administration (FDA) has approved first-time generic formulations for oxybutynin chloride tablets in the treatment of overactive bladder; ondasetron HCl injection and premixed injection for antiemetic use; and oxandrolone tablets for adjunctive use to promote weight gain in certain settings.

Generic Oxybutynin ER Tablets (Ditropan XL) for Overactive Bladder and More

On November 9, the FDA approved first-time generic formulations for oxybutynin chloride 5- and 10-mg extended-release tablets (made by Mylan Pharmaceuticals, Inc) and oxybutynin 15-mg extended release tablets (made by Impax Laboratories, Inc; brand name Ditropan XL, made by Alza Corporation [a Johnson & Johnson Company).

Oxybutynin extended-release tablets are indicated for once-daily therapy for the treatment of overactive bladder in patients with symptoms of urge urinary incontinence, urgency, and frequency. In this formulation, oxybutynin may also be used for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (eg, spina bifida).

Generic Ondasetron Injection Formulations (Zofran) for Antiemetic Use

On November 22, the FDA approved first-time generic formulations for ondasetron HCl 2-mg/mL injection packaged in single (4-mg/2-mL) and multidose (40-mg/20-mL) vials (made by Teva Pharmaceuticals USA; brand name Zofran, made by GlaxoSmithKline [GSK]).

A generic formulation for premixed 32-mg/50-mL ondasetron injection in 5% dextrose (50-mL flexible plastic containers) was also approved (made by Sicor Pharmaceuticals, Inc; brand name Zofran Injection Premixed, made by GSK).

According to an FDA news release, GSK agreed to waive the remainder of a 6-month exclusivity period so that the generic products could be approved.

Generic formulations for ondasetron 4- and 8-mg orally disintegrating tablets (made by Kali Laboratories, Inc, Bedford Laboratories, Mayne Pharma USA, Inc, and Taro Pharmaceuticals USA, Inc; brand name Zofran ODT, made by GlaxoSmithKline) were previously approved on November 18, 2005.

Ondasetron injection and premixed injection are indicated for the prophylaxis of postoperative nausea and vomiting, and nausea/vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin.

Generic Oxandrolone Tablets (Oxandrin) for the Promotion of Weight Gain and More

On December 1, the FDA approved a first-time generic formulation for oxandrolone 2.5- and 10-mg tablets (made by Impax Laboratories, Inc; brand name Oxandrin, made by Savient Pharmaceuticals, Inc).

Oxandrolone is an anabolic androgenic steroid indicated for adjunctive therapy to promote weight gain after weight loss due to extensive surgery, chronic infection, or severe trauma. It is also used to offset protein catabolism associated with prolonged use of corticosteroids, for relief of bone pain due to osteoporosis, and for idiopathic weight loss/inability to maintain weight.

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