Respirent Pharmaceuticals and Lannett received final approval from the US FDA for a Generic version of Advair Diskus.
Please see announcement by CNBC TV18
https://www.cnbctv18.com/market/usfda-nod-for-advair-generic-positive-for-aurobindo-pharma-but-negative-for-cipla-here-is-why-19819787.htm
All Studies (Therapeutic Equivalence-Bioequivalence study with Clinical Endpoints and Bioequivalence studies with Pharmacokinetic Endpoints) were conducted by BECRO.
This shows the efficiency and reliability of BECRO in conducting successful studies.
BECRO is specialized in the conduct of
- Therapeutic Equivalence (Non-Inferiority) studies (Bioequivalence studies with Clinical End-points) for Topical Generic products:
- Ophthalmic (leading CRO in Europe),
- Inhalers,
- Dermatological,
- Anesthetics and NSAIDs,
- Suppositories,
- Nasal,
- Otic.
- Bioequivalence-Pharmacokinetic studies.
- Clinical investigations for Medical Devices.
BECRO has been inspected by US FDA twice for data integrity and compliance with 21 CFR Part 320 – Bioavailability and Bioequivalence (BE), and the outcome of the inspections was positive with No Observations. Also, FDA has inspected six times the Clinical Facilities where BECRO conducts Therapeutic Equivalent studies; No Form-483 was issued.