CDSCO Panel Denies Pfizer Products India request for local CT waiver to market Elranatamab solution for injection
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-06-26 12:30 GMT | Update On 2024-06-26 12:30 GMT
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New Delhi: Noting that no new data, literature, or updates have been presented by the firm, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has rejected the drug major Pfizer Products India's proposal for waiver of local clinical trials for the grant of permission to import and market Elranatamab solution for injection.
This came after the proposal was redeliberated for the grant of permission to import and market Elranatamab solution for injection 44mg/1.1mL (40 mg/mL) and 76 mg/1.9 mL (40 mg/mL), along with a request for a local clinical trial waiver.
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