First-Time Generic Approvals: Novantrone, Terazol 3, Norco

Yael Waknine

April 14, 2006

April 14, 2006 -- The US Food and Drug Administration (FDA) has approved first-time generic formulations of mitoxantrone HCl 2-mg/mL injection for the treatment of multiple sclerosis, prostate cancer, and acute nonlymphocytic leukemia in adults; terconazole 80-mg vaginal suppositories for the treatment of vulvovaginal candidiasis; and a new 7.5-mg/300-mg strength of hydrocodone bitartrate plus acetaminophen tablets for use in the management of moderate to moderately severe pain.

Generic Mitoxantrone 2-mg/mL Injection (Novantrone) for MS, Prostate Cancer, and ANLL

On April 11, the FDA approved a first-time generic formulation for mitoxantrone HCl 2-mg/mL injection (made by Teva Pharmaceutical Industries Ltd; brand name Novantrone, made by Serono, Inc).

According to a company news release, shipments of the product are expected to begin immediately.

Mitoxantrone injection is indicated for reducing neurologic disability and/or the frequency of clinical relapses associated with secondary progressive, progressive relapsing, or worsening relapsing-remitting MS.

It is also indicated for use in combination with corticosteroids as initial chemotherapy for pain related to advanced hormone-refractory prostate cancer and as part of primary combination therapy for acute nonlymphocytic leukemia (ANLL) in adults.

Generic Terconazole 80-mg Suppositories (Terazol 3) for Vulvovaginal Candidiasis

On March 17, the FDA approved a first-time generic formulation for terconazole 80-mg vaginal suppositories (made by Perrigo Company; brand name Terazol 3, made by Ortho-McNeil Pharmaceuticals, Inc, a Johnson and Johnson Company).

According to a company news release, product shipments are expected to begin immediately.

Terconazole 80-mg vaginal suppositories are indicated for the local treatment of vulvovaginal candidiasis, as confirmed by KOH smears and/or cultures. The product should be administered intravaginally once daily at bedtime for 3 consecutive days.

Generic Hydrocodone Bitartrate Plus APAP Tablets (Norco) for Pain Management

On March 24, the FDA approved a first-time generic formulation and strength of hydrocodone bitartrate plus acetaminophen (APAP) tablets 7.5-mg/300-mg tablets (made by Mikart, Inc; brand name Norco 7.5-mg/325-mg tablets, made by Watson Pharmaceuticals, Inc).

Generic hydrocodone plus acetaminophen 5-mg/300-mg tablets were previously approved by the FDA on February 19. The products are indicated for the relief of moderate to moderately severe pain.

Reviewed by Gary D. Vogin, MD

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