Shares of Lupin rose over 4% in opening deals on Friday, reversing previous session losses, after the drug maker received approval from the United States Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA), Mirabegron Extended-Release Tablets. The drug, which is used for the treatment of overactive bladder with symptoms of urgency, urgency incontinence, and urinary frequency, will be manufactured at Lupin’s facility in Nagpur, India.
“Lupin has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Mirabegron Extended-Release Tablets, 25 mg and 50 mg, to market a generic equivalent of Myrbetriq® Extended-Release Tablets, 25 mg and 50 mg, of Astellas Pharma Global Development, Inc,” the drug major said in a release on Thursday.
As per the release, Mirabegron Extended-Release Tablets, 25 mg and 50 mg, had estimated annual sales of $2,403 million in the U.S. as of June 2022.
In a separate development, the Mumbai-based company also announced the launch of Sildenafil for Oral Suspension, 10 mg/mL, having received an approval from the U.S. FDA. The drug is used for the treatment of pulmonary arterial hypertension (PAH), a condition that causes high blood pressure in the lungs.
“Sildenafil for Oral Suspension, 10 mg/mL, is a generic equivalent of Revatio® for Oral Suspension, 10 mg/mL of Viatris Specialty LLC,” it said in a filing on Thursday.
Boosted by the developments, Lupin shares opened higher at ₹660, against the previous closing price of ₹654 on the BSE. The stock gained as much as 4.35% to hit a high of ₹682.5, while market capitalisation climbed to ₹30,986 crore.
In the previous session, Lupin shares dropped 2.3% after the company received a warning letter for its Tarapur, Maharashtra facility. In an exchange filing, the drug maker said it received a warning letter from the United States Food and Drug Administration (USFDA) for the company’s Tarapur (Maharashtra) facility, following inspection from March 22, 2022 to April 4, 2022.
“The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility,” it said.
“We are committed to addressing the concerns raised by the U.S. FDA and will work with the U.S. FDA to resolve these issues at the earliest. We uphold quality and compliance issues with utmost importance and remain committed to be compliant with CGMP quality standards across all our facilities,” it added.