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ATELVIA

TRACKED

CASHSN
THERAPEUTIC AREAS
MOLECULE INTELLIGENCE SNAPSHOTlive
14
Manufacturers monitored
38
Intelligence briefs
3
Active regulatory actions
₹2,800 Cr
Est. India export value

INTELLIGENCE

Showing 1 of 1 briefs for ATELVIA
CLINICAL & PIPELINE·Drug Approval

FDA Approves APIL's ATELVIA (Risedronate Sodium) as New Delayed-Release Dosage Form

The FDA approved APIL's NDA022560 for ATELVIA (Risedronate Sodium) as a Type 3 new delayed-release dosage form on October 8, 2010. This strategic approval for the 35MG oral tablet differentiates APIL's product in the market, necessitating ongoing regulatory and supply chain vigilance for this long-lifecycle asset, with updates extending to 2026.

90-Day Activity
MKMeera Krishnan· Senior Regulatory Intelligence Analyst
2020-08-18