Zydus Lifesciences gains FDA approval for Finasteride and Tadalafil Capsules

In a significant development for the pharmaceutical industry, Zydus Lifesciences Limited, previously known as Cadila Healthcare Limited, has secured final approval from the United States Food and Drug Administration (USFDA) to market its combination drug, Finasteride and Tadalafil Capsules USP, 5 mg/5 mg. This approval, announced recently, positions Zydus as the inaugural approved applicant for this specific drug combination, setting the stage for a 180-day exclusivity period under the Competitive Generic Therapy (CGT) exclusivity rights as stipulated in section 505(j)(5)(B)(v)(III) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The newly approved Finasteride and Tadalafil Capsules, 5 mg/5 mg, under the United States Reference Listed Drug (USRLD) designation of ENTADFI, mark a pivotal advancement in the treatment of benign prostatic hyperplasia (BPH). This exclusive formulation combines the benefits of both Finasteride and Tadalafil, offering a novel approach to managing the symptoms associated with BPH.

Zydus Lifesciences Limited’s achievement of being the “first approved applicant” for this combination therapy underscores its pioneering role in the pharmaceutical domain, particularly in the competitive landscape of generic drugs. The designation not only highlights the company’s commitment to innovation but also ensures its eligibility for 180 days of CGT exclusivity, providing a temporary market advantage over potential competitors.

The Finasteride and Tadalafil capsules will be manufactured in Zydus’s state-of-the-art formulation manufacturing facility located at Ahmedabad SEZ II, India. This facility is renowned for its adherence to global quality standards, ensuring that the products manufactured meet the rigorous safety and efficacy criteria set forth by regulatory bodies like the USFDA.

Zydus Lifesciences Limited’s latest approval from the USFDA adds to its growing portfolio of pharmaceutical products. The company now boasts 392 approvals, having filed over 460 Abbreviated New Drug Applications (ANDAs) since the beginning of its filing process in the fiscal year 2003-04. This milestone reflects Zydus’s persistent efforts in enhancing healthcare through the development of affordable and accessible medications.

The approval of Finasteride and Tadalafil Capsules not only signifies a breakthrough in BPH treatment but also demonstrates Zydus Lifesciences Limited’s dedication to addressing unmet medical needs. The company’s forward-thinking approach and continuous investment in research and development have positioned it as a key player in the global pharmaceutical industry.

The approval of Zydus Lifesciences Limited’s Finasteride and Tadalafil Capsules by the USFDA is a testament to the company’s innovation and its commitment to improving patient care. This combination therapy offers a new avenue for the treatment of benign prostatic hyperplasia, potentially improving the quality of life for many patients. With its 180-day exclusivity period, Zydus is set to make a significant impact in the market, reinforcing its position as a leader in the pharmaceutical industry.