Generic Product News: December 2023

Pharmacy TimesDecember 2023
Volume 89
Issue 12

The products include Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution, Icatibant Injection, Esomeprazole Magnesium Capsules, and Apremilast Tablets.

Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution, 0.5 g/mL

From: Lupin

Compare To: Xywav Oral Solution

PHTM Retail December 2023 Issue

The FDA offered tentative approval to an abbreviated new drug application for calcium, magnesium, potassium, and sodium oxybates oral solution, 0.5 g/mL. The novel treatment, indicated to manage narcolepsy, is the generic equivalent of the reference-listed drug (RLD) Xywav oral solution from Jazz Pharmaceuticals, Inc. Calcium, magnesium, potassium, and sodium oxybates solution is indicated to manage cataplexy and excessive daytime sleepiness in patients 7 years or older with narcolepsy. Calcium, magnesium, potassium, and sodium oxybates solution also has an indication for idiopathic hypersomnia in adult patients. The most common adverse events observed in patients taking the RLD include nausea, headache, dizziness, anxiety, insomnia, and fatigue.


Icatibant Injection

From: Aurobindo

Compare To: Firazyr

The FDA granted final approval to a bioequivalent and therapeutically equivalent generic form of icatibant injection in the dose of 30 mg/3 mL (10 mg/mL), according to a recent press release from Eugia, a subsidiary of Aurobindo. Icatibant injection is a single-dose prefilled syringe that is indicated to manage acute attacks of swelling caused by hereditary angioedema (HAE) in adults. HAE is a condition stemming from the overproduction of a signaling molecule called bradykinin. When the body produces too much bradykinin, the blood vessels become relaxed and release fluid into the surrounding tissues, leading to swelling. Icatibant is a molecule that blocks the bradykinin-sensing receptors to prevent swelling.


Esomeprazole Magnesium Capsules

From: Granules India

Compare To: Nexium Delayed-Release Capsules

Granules India received FDA approval for its esomeprazole magnesium capsules in strengths of 20 mg and 40 mg, which was recently announced in a regulatory filing. Esomeprazole magnesium capsules are indicated for the short-term management (4 to 8 weeks) of symptoms of gastroesophageal reflux disease (GERD), including heartburn. GERD is a condition that results in stomach contents moving back up the esophagus, irritating the esophageal lining and causing other symptoms. The generic medication is also indicated for shortterm use to reduce the risk of gastric ulcers associated with use of nonsteroidal anti-inflammatory drugs in adults and the longterm management of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome).


Apremilast Tablets

From: Glenmark Pharmaceuticals Ltd

Compare To: Otezla

Glenmark Pharmaceuticals Ltd received final approval from the FDA for its apremilast tablets of 10 mg, 20 mg, and 30 mg, according to a press release. Apremilast tablets are the generic form of the reference-listed drug Otezla (Amgen Inc) and are indicated for the management of psoriatic arthritis, plaque psoriasis, and Behçet syndrome, a condition of inflamed blood vessels. Apremilast is a phosphodiesterase 4 inhibitor that suppresses the immune system to reduce inflammation, which is usually involved with arthritis. The most common adverse events associated with apremilast tablets are headache, nausea, or cold symptoms, although some patients may have thoughts of suicide while on apremilast. Patients should consult their physician with new or worsening symptoms.


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