Generic Product News - September 2023

Cyanocobalamin Nasal Spray, 500 mcg/spray

From: Lupin Limited

Compare To: Nascobal

The FDA has approved an abbreviated new drug application for cyanocobalamin nasal spray, 500 mcg/spray, which is a generic vitamin B12 supplement to reference listed drug Nascobal Nasal Spray, 500 mcg/spray (Par Pharmaceutical Companies, Inc). Nascobal is a prescription medication used to treat vitamin B12 deficiency caused by food limitations, certain medication use, or B12 malabsorption unrelated to pernicious anemia. It is also indicated as maintenance therapy for low vitamin B12 levels in patients with pernicious anemia who have achieved healthy B12 levels, and as a preventive treatment of vitamin B12 deficiency.

FOR MORE INFORMATION: lupin.com

Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg

From: Lupin Pharmaceuticals, Inc

Compare To: Thorazine

Lupin Pharmaceuticals, Inc, a subsidiary of Lupin Limited, received a final nod from the FDA after submitting an abbreviated new drug application for chlorpromazine hydrochloride tablets USP in strengths 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg. Chlorpromazine is an antipsychotic medication often used for schizophrenia, nausea, vomiting, anxiety before surgery, and bipolar disorder. Common adverse events associated with chlorpromazine include drowsiness, dry mouth, stuffy nose, blurred vision, constipation, and impotence.

FOR MORE INFORMATION: lupin.com

Tiotropium Bromide Inhalation Powder, 18 mcg/ capsule

From: Lupin Pharmaceuticals, Inc

Compare To: Spiriva HandiHaler

Lupin was granted FDA approval for its tiotropium bromide inhalation powder USP 18 mcg/capsule. Tiotropium bromide inhalation powder is an anticholinergic that prevents bronchospasm, or the narrowing of lung airways, in patients with bronchitis, emphysema, or chronic obstructive pulmonary disease. The most common adverse events associated with tiotropium bromide inhalation powder are dry mouth, constipation, upset stomach, vomiting, nosebleed, and muscle pain. The recommended dose is 1 capsule, once daily. Tiotropium bromide inhalation powder has an approximate US market of $1.26 billion, according to March 2023 IQVIA data.

FOR MORE INFORMATION: lupin.com

Sevelamer Hydrochloride Tablets USP, 400 mg and 800 mg

From: APL Healthcare

Compare To: Renagel Tablets 400 mg and 800 mg

The FDA approved the abbreviated new drug application from APL Healthcare, a subsidiary of Aurobindo Pharma Limited, for sevelamer hydrochloride tablets in strengths 400 mg and 800 mg. Sevelamer hydrochloride tablets are indicated to control serum phosphorus levels in patients with chronic kidney disease who are currently on dialysis. APL Healthcare’s sevelamer hydrochloride tablets are the generic version of reference listed drug Renagel tablets 400 mg and 800 mg (Genzyme Corporation). Adverse reactions associated with this medication include gastrointestinal issues such as vomiting, nausea, diarrhea, dyspepsia, abdominal pain, flatulence, and constipation.

FOR MORE INFORMATION: aurobindo.com