Lupin, a prominent pharmaceutical player, witnessed a positive surge of 3% in its share prices on December 18, buoyed by the announcement of approval from the US Food and Drug Administration (USFDA) for its drugs targeting gout and diabetes.
According to the company’s regulatory filing, Lupin has received the coveted approval from the USFDA for its Abbreviated New Drug Application (ANDA) related to Allopurinol tablets USP, available in 100 mg and 300 mg variants. These tablets are intended to be marketed as a generic bioequivalent, offering therapeutic equivalence to the reference listed drug (RLD), Zyloprim Tablets, 100 mg, and 300 mg, by Casper Pharma, LLC.
Allopurinol Tablets USP, recognized for their effectiveness in managing adult patients exhibiting signs and symptoms of primary or secondary gout, serve a critical role in addressing various conditions associated with the ailment. This includes the management of acute attacks, tophi, joint destruction, uric acid lithiasis, and nephropathy.
Notably, Allopurinol finds application in adult and pediatric patients undergoing treatment for conditions such as leukaemia, lymphoma, and solid tumor malignancies, or those receiving cancer therapy that leads to elevated levels of serum and urinary uric acid.
Furthermore, Allopurinol is prescribed for treating adult patients experiencing recurrent calcium oxalate calculi, specifically in cases where daily uric acid excretion exceeds 800 mg/day for male patients and 750 mg/day for female patients.
Lupin highlighted that the manufacturing of these drugs will take place at its state-of-the-art facility in Pithampur, India, underscoring the company’s commitment to maintaining high-quality production standards.
The approval from the USFDA marks a significant milestone for Lupin, reinforcing its position as a key player in the pharmaceutical industry. The positive market response, with a 3% uptick in share prices, reflects the optimism surrounding Lupin’s foray into the market with its approved gout and diabetes drugs. Investors and industry stakeholders are keenly observing the company’s trajectory as it continues to make strides in providing effective healthcare solutions.
