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Apotex blood disorder therapy wins FDA nod as 1st competitive generic therapy

The U.S. Food and Drug Administration granted a competitive generic therapy designation to several strengths of Apotex Inc.'s potassium chloride oral solution to treat low potassium levels in certain patients.

Apotex's different doses of potassium chloride oral solution are the first generic drugs to receive the competitive generic therapy, or CGT, status, the U.S. regulator said in an Aug. 8 press release.

A drug can be designated as a CGT if it has "inadequate generic competition," meaning that there is not more than one approved drug in the active section of the orange book. The designation is meant to increase competition and lower the cost of expensive drugs in the market.

Drugs that receive the designation are eligible for review enhancements and expedited review of their applications. Applicants that receive the CGT status also qualify for a 180-day period of market exclusivity if they are the first approved applicant for that CGT and meet certain other conditions.

Potassium chloride is an oral treatment used to treat and prevent hypokalemia — a lower-than-normal potassium level in the bloodstream — in patients who are on diuretics, and when dietary management with potassium-rich foods is insufficient or diuretic dose reduction is not possible.

Low potassium levels can lead to abnormal heart rhythms, especially in people with heart disease, as well as lightheadedness, fainting, and even heart failure paralysis and death in extreme cases.