First-Time Generic Approvals: Sandostatin, Dantrium, Grifulvin V, Depo-Medrol

Yael Waknine

April 13, 2005

April 13, 2005 — The U.S. Food and Drug Administration (FDA) has approved first-time generic formulations of octreotide acetate preservative-free injection for the treatment of acromegaly and for symptomatic treatment of metastatic carcinoid and vasoactive intestinal peptide-secreting tumors; dantrolene sodium capsules for controlling manifestations of clinical spasticity due to upper motor neuron disorders and for the prevention of malignant hyperthermia; griseofulvin oral suspension for the treatment of infections caused by susceptible dermatophytes; and methylprednisolone acetate injectable suspension for the treatment of conditions requiring injectable corticosteroid therapy.

Generic Octreotide (Sandostatin) for Acromegaly, Symptomatic Treatment of Certain Tumors

On March 28, the FDA approved generic formulations of octreotide acetate 0.05 mg/mL, 0.1 mg/mL, and 0.5 mg/mL preservative-free injection (made by Bedford Laboratories, Inc; brand name Sandostatin, made by Novartis Pharmaceuticals Corp).

Octreotide acetate injection is indicated for the reduction of growth hormone and somatomedin C blood levels associated with acromegaly; for the suppression or inhibition of flushing and diarrhea episodes associated with metastatic carcinoid tumors; and for the treatment of profuse watery diarrhea associated with vasoactive intestinal peptide–secreting tumors.

Generic Dantrolene Sodium Capsules (Dantrium) for Spasticity, Prevention of Malignant Hyperthermia

On March 1, the FDA approved first-time generic formulations of dantrolene sodium 25-, 50-, and 100-mg capsules (made by Impax Laboratories, Inc; brand name Dantrium, made by Proctor & Gamble Co).

Dantrolene sodium capsules are indicated for controlling manifestations of clinical spasticity resulting from upper motor neuron disorders such as spinal cord injury, stroke, cerebral palsy, or multiple sclerosis. It is also indicated for use in preventing recurrence after treatment of an acute episode and preventing or attenuating the development of malignant hyperthermia in susceptible patients who require anesthesia and/or surgery.

Generic Griseofulvin Oral Suspension (Grifulvin V) for Ringworm and Onychomycosis

On March 2, the FDA approved a first-time generic formulation of griseofulvin 125 mg/5 mL oral suspension (made by Stiefel Laboratories, Inc; brand name Grifulvin V, made by Johnson & Johnson, Inc).

Griseofulvin 125 mg/5 mL oral suspension is indicated for the treatment of infections caused by susceptible dermatophytes.

Generic Methylprednisolone Acetate Injectable Suspension (Depo-Medrol) for Conditions Requiring Systemic Steroid Therapy

On Feb. 23, the FDA approved first-time generic formulations of methylprednisolone acetate 40 mg/mL and 80 mg/mL injectable suspension (made by Sicor Pharmaceuticals, Inc; brand name Depo-Medrol, made by Pfizer, Inc).

Methylprednisolone acetate injectable suspension is indicated for the treatment of a variety of conditions requiring administration of injectable corticosteroids, including acute lymphocytic leukemia, adrenocortical insufficiency, allergic rhinitis, atopic dermatitis, inflammatory bowel disease, transplant rejection, and rheumatoid arthritis.

Reviewed by Gary D. Vogin, MD

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