Last Updated on October 18, 2024 by The Health Master
USFDA approval
Aurobindo Pharma, a leading global generic pharmaceutical company, has achieved a significant milestone with the U.S. Food and Drug Administration approval (USFDA approval) for its Cephalexin Tablets USP, 250 mg and 500 mg.
This USFDA approval marks a significant step forward for the company’s presence in the U.S. market.
Product Details and Equivalence
- Bioequivalence: Aurobindo’s Cephalexin Tablets are bioequivalent to Keflet Tablets, a brand-name product manufactured by Eli Lilly and Company. This means the generic version will have the same therapeutic effect as the original.
- Therapeutic Equivalence: The generic drug is also therapeutically equivalent, ensuring it can be used interchangeably with the brand-name medication.
Competitive Generic Therapy (CGT) Designation
- Shared Exclusivity: Aurobindo Pharma has been awarded the Competitive Generic Therapy (CGT) designation for its Cephalexin Tablets. This grants the company a 180-day period of shared generic drug exclusivity, providing a temporary market advantage.
Intended Use and Indications
- Treatment of Infections: Cephalexin Tablets are indicated for the treatment of infections caused by susceptible strains of various microorganisms. This includes both gram-positive and gram-negative bacteria.
Company’s Growth and Achievements
- Strong USFDA Approval Record: Aurobindo Pharma has a robust track record of securing USFDA approvals for its generic products. With this latest USFDA approval, the company now has a total of 523 ANDA approvals, including 506 final approvals and 17 tentative approvals.
In conclusion, the USFDA’s approval of Aurobindo Pharma’s generic Cephalexin Tablets is a testament to the company’s commitment to providing affordable and quality medications to patients.
This achievement further strengthens Aurobindo’s position as a leading player in the global generic pharmaceutical market.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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