First-Time Generic Approvals: Phenergan Tablets, Floxin Otic, Sodium Bicarbonate Injection

Yael Waknine

January 04, 2006

Jan. 4, 2006 — The US Food and Drug Administration (FDA) approved in November 2005 first-time generic formulations of promethazine HCl 12.5-, 25-, and 50-mg tablets for approved indications in patients aged 2 years and older; ofloxacin 0.3% otic solution for the treatment of certain ear infections caused by designated strains of susceptible microorganisms; and sodium bicarbonate 7.5% (0.9 mEq/mL) and 8.4% (1 mEq/mL) injection in prefilled 50-mL syringes for the treatment of metabolic acidosis, certain drug intoxications, and severe diarrhea.


Generic 12.5-, 25-, and 50-mg Promethazine HCl Tablets (Phenergan) for Approved Indications

On November 18, the FDA approved first-time generic formulation of promethazine HCl 12.5-, 25-, and 50-mg tablets (made by Zydus Pharmaceuticals USA, Inc; brand name Phenergan, made by Wyeth Pharmaceuticals, Inc).

Promethazine is indicated for use in patients aged 2 years and older for the treatment of perennial and seasonal allergic rhinitis; vasomotor rhinitis; allergic conjunctivitis due to inhalant allergens and foods; mild, uncomplicated allergic skin manifestations of urticaria and angioedema; amelioration of allergic reactions to blood or plasma; dermographism; and as adjunctive therapy to epinephrine and other standard measures for treatment of anaphylactic reactions after acute manifestations have been controlled.

The drug is also indicated for preoperative, postoperative, or obstetric sedation; prevention and control of nausea/vomiting associated with certain types of anesthesia and surgery; sedation in children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused; active and prophylactic treatment of motion sickness; and as antiemetic therapy for postoperative patients.


Generic Ofloxacin 0.3% Otic Solution (Floxin) for Designated Ear Infections

On November 18, the FDA approved a first-time generic formulation of ofloxacin 0.3% otic solution (made by Apotex, Inc; brand name Floxin, made by Daiichi Pharmaceutical Corporation).

Ofloxacin otic solution is indicated for the treatment of ear infections caused by susceptible strains of designated microorganisms. It may be used in patients aged 6 months and older with otitis externa due to Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus.

It is also indicated for the treatment of chronic suppurative otitis media due to P mirabilis, P aeruginosa, and S aureus in patients aged 1 year and older with perforated tympanic membranes, and acute otitis media due to Haemophilus influenzae, Moraxella catarrhalis, P aeruginosa, S aureus, and Streptococcus pneumoniae in pediatric patients aged 1 year and older with tympanostomy tubes .


Generic Sodium Bicarbonate 7.5% and 8.4% Injection for Metabolic Acidosis, Drug Intoxication, Severe Diarrhea

On November 9, the FDA approved new generic formulations of sodium bicarbonate 7.5% (0.9 mEq/mL) and 8.4% (1 mEq/mL) injection in prefilled 50-mL single-dose ANSYR II syringes (made by Hospira, Inc).

Previously available generic formulations of the product (packaged in Abboject vials by Abbott Laboratories) were discontinued for reasons unrelated to safety or efficacy.

Sodium bicarbonate injection is indicated for the treatment of metabolic acidosis that occurs in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest, and severe primary lactic acidosis.

It is also indicated for the treatment of certain drug intoxications (including barbiturates, poisoning by salicylates or methyl alcohol, and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments), and severe diarrhea which is often accompanied by a significant loss of bicarbonate.

Reviewed by Gary D. Vogin, MD

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