MAP Pharmaceuticals (MAPP) Receives FDA CRL for LEVADEX
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Late Monday, MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced the FDA issued a Complete Response letter (CRL) to its New Drug Application (NDA) for LEVADEX inhalation aerosol.
In the CRL, the FDA requested that the Company address issues relating to chemistry, manufacturing and controls (CMC) and observations from a recent facility inspection of a third party manufacturer. The FDA also indicated that it had not been able to complete review of inhaler usability information requested late in the review cycle by the FDA.
The FDA did not cite any clinical safety or efficacy issues, nor did the FDA request that any additional clinical studies be conducted prior to approval.
MAP Pharmaceuticals will Host Conference Call on Tuesday, March 27, 8:00 a.m. Eastern Time.
Shares remain halted on the NASDAQ at this time.
In the CRL, the FDA requested that the Company address issues relating to chemistry, manufacturing and controls (CMC) and observations from a recent facility inspection of a third party manufacturer. The FDA also indicated that it had not been able to complete review of inhaler usability information requested late in the review cycle by the FDA.
The FDA did not cite any clinical safety or efficacy issues, nor did the FDA request that any additional clinical studies be conducted prior to approval.
MAP Pharmaceuticals will Host Conference Call on Tuesday, March 27, 8:00 a.m. Eastern Time.
Shares remain halted on the NASDAQ at this time.
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