Zydus Lifesciences gets US FDA nod to market Metronidazole Topical cream in US

Zydus Lifesciences on Tuesday said it has received final approval from the drug regulator US FDA to manufacture and market Metronidazole Topical cream in the US market.

Metronidazole is an antibiotic used on the skin to treat a certain skin disorder known as rosacea, a type of adult acne. It is expected to help decrease redness, swelling, and the number of pimples caused by rosacea and is believed to work by decreasing swelling (inflammation).

The pharmaceutical company in a regulatory filing said, "Zydus Lifesciences Ltd (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (US FDA) to manufacture and market Metronidazole Topical Cream, 0.75% (USRLD: MetroCream, 0.75%)."

Zydus Lifesciences says that the drug will be manufactured at the group’s topical manufacturing facility at Changodar, Ahmedabad (India).

Metronidazole Topical Cream, 0.75% had annual sales of $25 million in the United States (IQVIA MAT Feb. 2023).

Zydus Lifesciences, earlier on April 24, 2023, received final approval from the US FDA for Icosapent Ethyl Capsules that is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.

On April 20, 2023, the company got US FDA nod to manufacture and market Metoprolol Tartrate Tablets, a drug that is used with or without other medications to treat high blood pressure (hypertension).

Similarly, Zydus Lifesciences received US FDA final nod for other drugs in April 20213 and some of those are:

Acetazolamide Tablets USP, 125 mg and 250 mg that is used to treat Glaucoma, a condition in which increased pressure in the eye can lead to gradual loss of vision.

Carbidopa and Levodopa Tablets USP, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg, is used to treat symptoms of Parkinson's disease.

Azithromycin Tablets USP, 500 mg is used to treat bacterial infections.

Tavaborole Topical Solution, 5% is a drug that is used to treat fungal toenail infections.

Isoproterenol Hydrochloride Injection, a drug indicated to improve hemodynamic status

Estradiol Transdermal System USP, 0.014 mg/day, a drug for postmenopausal osteoporosis.

Roflumilast Tablets, 250 mcg is a drug used to reduce inflammation in the lungs.

Shares of Zydus Lifesciences were trading at Rs 517.80 per share, up 0.16 percent, at 3:01 pm on NSE.