Generic Product News: June 2021

Potassium Citrate Extended-Release Tablets

Marketed by Camber Pharmaceuticals

Compare to: Urocit-K
Patients with renal tubular acidosis (RTA), a kidney stone condition, have a new generic option with Camber’s launch of potassium citrate extended-release tablets. RTA occurs when the kidneys fail to excrete acids into the urine, causing patients’ blood to remain too acidic. Symptoms include confusion, decreased alertness, fatigue, impaired growth in children, and kidney stones. Potassium citrate tablets produce an alkaline load that increases urinary pH. Common adverse effects include diarrhea, nausea, stomach pain, and vomiting.

Sapropterin Dihydrochloride Powder for Oral Solution

Manufactured by Dr. Reddy’s Laboratories

Compare to: Kuvan
Indicated to lower blood phenylalanine (Phe) levels in adults and children over 1 month of age with phenylketonuria, the new generic sapropterin dihydrochloride powder from Dr. Reddy’s Laboratories is available in 100-mg unit-dose packets in a 30-count carton. Phenylketonuria is an inborn error of metabolism that results in decreased metabolism of the amino acid Phe, which can lead to behavioral problems, intellectual disability, mental disorders, and seizures if left untreated. Sapropterin dihydrochloride hydroxylates Phe through an oxidative reaction to form tyrosine, thereby improving the normal oxidative metabolism of Phe. Adverse reactions can include cough, diarrhea, headache, nasal congestion, and vomiting.

Potassium Chloride Extended-Release Tablets

Manufactured by Aurobindo

Compare to: Merck Potassium Chloride Extended-Release Tablets
The FDA has approved Aurobindo’s generic potassium chloride extended-release tablets in dosage strengths of 10, 15, and 20 mEq. They are indicated for the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemia familial period paralysis. They can also be used for the prevention of hypokalemia in patients who would be at particular risk if it were to develop. Potassium chloride is an electrolyte replenisher intended to slow the release of potassium and reduce the likelihood of a high localized concentration of potassium chloride in the gastrointestinal tract.

Azelastine HCI Nasal Spray 0.1%

Manufactured by Aurobindo

Compare to: Astelin
With the launch of azelastine hydrochloride (HCI) nasal spray 0.1%, Aurobindo has introduced its first product in the United States with a pump nasal spray delivery system. The medication is used to relieve nasal symptoms caused by allergies or other conditions and works by blocking histamines. Adverse effects can include a bitter taste in the mouth, a burning feeling in the nose, drowsiness, cough, dry mouth, headache, nausea, nose bleeds, runny nose, and sneezing fits.