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  • Zydus Lifesciences...

Zydus Lifesciences gets USFDA okay for Finasteride and Tadalafil Capsules

Written By : Susmita Roy |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-03-18T11:52:58+05:30  |  Updated On 20 March 2024 3:07 PM IST
Aurobindo Pharma gets USFDA final, tentative nod for different strengths of deep vein thrombosis drug Rivaroxaban
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Tadalafil is used to treat benign prostatic hyperplasia.

Ahmedabad: Zydus Lifesciences Limited has announced that the Company has received final approval from the United States Food and Drug Administration (USFDA) to market Finasteride and Tadalafil Capsules USP 5 mg/5 mg. (USRLD: ENTADFI TM).

"Zydus is the “first approved applicant” for Finasteride and Tadalafil Capsules, 5 mg/5 mg, as defined in section 505(j)(5)(B)(v)(III) of the FD&C Act and therefore is eligible for 180 days of CGT exclusivity," the Company stated.

Tadalafil is used to treat benign prostatic hyperplasia.

Benign prostatic hyperplasia is also known as prostate enlargement. In this disease, there is a noncancerous increase in size of the prostate gland. Symptoms may include Weak stream, frequent urination, trouble starting to urinate, inability to urinate, or loss of bladder control.

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ II, India.

The group now has 392 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04.

Read also: Zydus Lifesciences bags USFDA tentative nod for Edaravone Injection to treat amyotrophic lateral sclerosis

Medical Dialogues team had earlier reported that the Company had received final approval from the USFDA to market Silodosin Capsules, 4 mg and 8 mg (USRLD: Rapaflo capsules). Silodosin capsules are indicated to treat signs and symptoms of an enlarged prostate gland, which is also known as benign enlargement of the prostate (benign prostatic hyperplasia or BPH).

Read also: Zydus Lifesciences bags USFDA nod for Silodosin, Pregabalin capsules

Headquartered in Ahmedabad, Zydus Lifesciences Limited is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs. The group employs over 26,000 people worldwide, including 1,400 scientists engaged in R & D.

Read also: Zydus Lifesciences wins USFDA nod for Chlorpromazine Hydrochloride Injection for certain mental disorders

zydus lifescienceszydus lifesciences newsUSFDAFinasteride and Tadalafil Capsulesbenign prostatic hyperplasia
Susmita Roy
Susmita Roy

    Mpharm (Pharmacology)

    Susmita Roy, B pharm, M pharm Pharmacology, graduated from Gurunanak Institute of Pharmaceutical Science and Technology with a bachelor's degree in Pharmacy. She is currently working as an assistant professor at Haldia Institute of Pharmacy in West Bengal. She has been part of Medical Dialogues since March 2021.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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