Zydus Lifesciences gets final USFDA approval for antifungal drug

Zydus Lifesciences, formerly known as Cadila Healthcare, on Wednesday said it has received final nod from the U.S. drug regulator to market its antifungal medicine Micafungin drug, which is used for the treatment of certain kinds of fungal or yeast infections. This is the seventh drug approval received by the pharma major from the U.S. Food and Drug Administration (USFDA) so far this month.

“The company has received final approval from the United States Food and Drug Administration (USFDA) to market Micafungin for Injection, 50 mg/vial and 100 mg/vial, single-dose vials (USRLD: Mycamine),” says an exchange filing by Zydus Lifesciences.

Micafungin is indicated to treat a variety of fungal infections, while it is also used to prevent fungal infections in patients who are having a stem cell transplant.

As per the company, the drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara, India.

Micafungin for Injection had annual sales of $99 million in the United States, according to IQVIA data, a global healthcare data and solutions provider.

Overall, the group has so far received 329 approvals and filed over 428 abbreviated new drug applications (ANDAs) since the commencement of the filing process in the financial year 2003-04. The ANDA is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.

Last week, the Ahmedabad- headquartered company received final approval from the U.S. health regulator to market Ketorolac Tromethamine Tablets, which is used to relieve moderately severe pain, usually after surgery. Ketorolac Tromethamine Tablets USP, 10 mg (USRLD: Toradol), will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.

Besides, the company’s subsidiary, Zydus Worldwide DMCC, also received tentative nods for its generic versions of Valbenazine capsules and Roflumilast tablets. While Valbenazine Capsules are used for the treatment of adults with tardive dyskinesia (movements in the face, tongue, or other body parts that cannot be controlled), Roflumilast Tablets are used for reducing risk of chronic obstructive pulmonary disease in severely affected patients associated with chronic bronchitis and a history of exacerbations. Both the drugs will be manufactured at the group’s formulation manufacturing facility at Ahmedabad.

Earlier this month, the drug maker got final nod for high blood pressure drug, Sildenafil for Oral Suspension, and Mirabegron Extended-Release Tablets, used for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. It also received tentative approval for antidyskinetic medicine Amantadine Extended-Release Capsules and anti-epileptic drug Brivaracetam Tablets. All these drugs will be manufactured at the group’s formulation manufacturing facility at Ahmedabad, Gujarat.

On Tuesday, Zydus Lifesciences shares closed 0.99% higher at ₹417.25 apiece on the Bombay Stock Exchange. The pharma stock has delivered a negative return of 18% in the past one year, while it has surged 19.5% over a six month period. In the last one month, the stock has risen more than 17% as compared to 4% growth in BSE benchmark Sensex.