Indoco Remedies scores major FDA win with exclusive approval for Lofexidine Tablets

Indoco Remedies scores major FDA win with exclusive approval for Lofexidine Tablets

Indoco Remedies Limited has achieved a pivotal milestone with the final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lofexidine Tablets, 0.18 mg. This approval authorizes Indoco to market a generic equivalent of Lucemyra Tablets, 0.18 mg, which are manufactured by USWM, LLC. This announcement includes […]

Zydus Lifesciences gains FDA approval for Finasteride and Tadalafil Capsules

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 […]