CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

205874Orig1s000

CHEMISTRY REVIEW(S)

---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------

MONICA D COOPER07/29/2014For Review of the Drug Substance

THOMAS M WONG07/29/2014Thomas Wong reviewed the drug product portion of the application.

OLEN M STEPHENS07/29/2014

Reference ID: 3600789

---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------

MONICA D COOPER03/31/2014

THOMAS M WONG03/31/2014

OLEN M STEPHENS03/31/2014CMC Recommendation is for a complete response action. A draft list of deficiency comments areattached to the end of the review.

Reference ID: 3480928

7.

Are drug substance manufacturing sites identified on FDA Form 356h or associated continuation sheet? For each site, does the application list: • Name of facility, • Full address of facility including

street, city, state, country • FEI number for facility (if

previously registered with FDA) • Full name and title, telephone, fax

number and email for on-site contact person.

• Is the manufacturing responsibility and function identified for each facility?, and

• DMF number (if applicable)

X

8.

Are drug product manufacturing sites are identified on FDA Form 356h or associated continuation sheet. For each site, does the application list: • Name of facility, • Full address of facility including

street, city, state, country • FEI number for facility (if

previously registered with FDA) • Full name and title, telephone, fax

number and email for on-site contact person.

• Is the manufacturing responsibility and function identified for each facility?, and

• DMF number (if applicable)

X

9.

Are additional manufacturing, packaging and control/testing laboratory sites are identified on FDA Form 356h or associated continuation sheet. For each site, does the application list: • Name of facility, • Full address of facility including

street, city, state, country • FEI number for facility (if

previously registered with FDA) • Full name and title, telephone, fax

number and email for on-site contact person.

• Is the manufacturing responsibility and function identified for each facility?, and

• DMF number (if applicable)

X

Reference ID: 3365503

---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------

KASTURI SRINIVASACHAR08/29/2013

RAMESH K SOOD08/30/2013

Reference ID: 3365503