August Generic Product News

Pharmacy TimesAugust 2023
Volume 89
Issue 8

This months generic product news includes azithromycin tablets, minocycline hydrochloride tablets, carboprost tromethanmine injection, and tadalafil tablets.

Azithromycin Tablets USP 500 mg

From: Zydus Lifesciences Limited

Compare To: Zithromax tablets

The FDA recently granted final approval to azithromycin tablets USP 500 mg to treat various bacterial infections, including pneumonia, sexually transmitted infections, and bronchitis, along with infections of the ears, lungs, sinuses, skin, throat, and reproductive organs. The most common adverse events associated with azithromycin include diarrhea, nausea, vomiting, headache, and stomach pain. Severe adverse events can include severe stomach pain, watery or bloody diarrhea, irregular heartbeat, shortness of breath, sudden dizziness, and liver problems.

For more information:

A group of antibiotic pill capsules falling. Healthcare and medical 3D illustration background. | Image credit: James Thew -

A group of pill capsules falling | Image credit: James Thew -

Minocycline Hydrochloride Extended-Release Tablets USP 55 mg, 65 mg, and 115 mg

From: Zydus Lifesciences Limited

Compare To: Ximino capsules

The FDA gave final approval to minocycline hydrochloride extended-release tablets in 55 mg, 65 mg, and 115 mg for the treatment of moderate to severe acne in patients 12 years and older. Minocycline is a tetracycline antibiotic that stops the growth of bacteria thought to worsen acne. Minocycline hydrochloride extended-release tablets do not work for infections caused by a virus, including flu. The most common adverse events associated with minocycline hydrochloride extended-release tablets include nausea, vomiting, diarrhea, lightheadedness, dizziness, and a feeling of spinning.

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Carboprost Tromethamine Injection USP 250 mcg/mL, Single-Dose Vials

From: Aurobindo Pharma

Compare To: Hemabate Sterile Solution, 250 mcg/mL

Eugia Pharma Specialties (an Aurobindo Pharma subsidiary) has received FDA approval to manufacture and market carboprost tromethamine injection USP 250 mcg/mL in single-dose vials. The injection is the generic form of Pfizer Inc’s Hemabate Sterile Solution, 250 mcg/mL, and it is indicated for aborting pregnancy during gestation (weeks 13-20); it is also indicated for hemorrhage caused by uterine atony. The most common adverse reactions are vomiting, diarrhea, nausea, a temperature increase greater than 2 °F, and flushing, although reactions are generally transient and reversible after treatment.

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Tadalafil Tablets USP 20 mg

From: Zydus Lifesciences Limited

Compare To: Adcirca

The FDA has approved tadalafil tablets USP 20 mg to treat symptoms of pulmonary arterial hypertension. Tadalafil tablets are effective because they relax arteries to increase blood flow throughout the body and improve exercise capacity, which may decrease clinical worsening of symptoms. Patients are advised to take no more than two 20-mg doses of tadalafil once daily to improve hypertension. The drug is generally well tolerated, with the most common adverse effects being headache, muscle pain, nasal stuffiness, skin flushing, respiratory infection, upset stomach, and muscle pain.

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