@gregoryglass
Search
Latest updates
Product: Lexiscan®(regadenoson) Injection
Company: Astellas
Petition Filer: IDRS Labs
Petition Number(s): 2021P-0389
Date of Petition: April 15, 2021
Responding Petitions:Issue and Implication: Whether the product from an ANDA filer must have the same packaging configuration in order to be “A” rated.
Action Requested by…Read more
Product: Belviq®(lorcaserin) and Bacitracin
Company: Eisai and others
Petition Filer: Public Citizen
Petition Number(s): 2021P-0378
Date of Petition: April 13, 2021
Responding Petitions:Issue and Implication: Whether current FDA practice regarding products removed from the market for safety reasons is sufficient to ensure…Read more
Product: Sutab®(magnesium sulfate et al) Tablets and other tablet colonoscopy preps
Company: Braintree
Petition Filer: Braintree
Petition Number(s): 2021P-0376
Date of Petition: April 13, 2021
Responding Petitions:Issue and Implication: Whether current approval standards for NDAs and ANDAs is sufficient to ensure efficacy of…Read more
Latest updates
Product: Lexiscan®(regadenoson) Injection
Company: Astellas
Petition Filer: IDRS Labs
Petition Number(s): 2021P-0389
Date of Petition: April 15, 2021
Responding Petitions:Issue and Implication: Whether the product from an ANDA filer must have the same packaging configuration in order to be “A” rated.
Action Requested by…Read more
Product: Belviq®(lorcaserin) and Bacitracin
Company: Eisai and others
Petition Filer: Public Citizen
Petition Number(s): 2021P-0378
Date of Petition: April 13, 2021
Responding Petitions:Issue and Implication: Whether current FDA practice regarding products removed from the market for safety reasons is sufficient to ensure…Read more
Product: Sutab®(magnesium sulfate et al) Tablets and other tablet colonoscopy preps
Company: Braintree
Petition Filer: Braintree
Petition Number(s): 2021P-0376
Date of Petition: April 13, 2021
Responding Petitions:Issue and Implication: Whether current approval standards for NDAs and ANDAs is sufficient to ensure efficacy of…Read more
Search Forums
Login
Recent Topics
Login
Latest updates
Product: Lexiscan®(regadenoson) Injection
Company: Astellas
Petition Filer: IDRS Labs
Petition Number(s): 2021P-0389
Date of Petition: April 15, 2021
Responding Petitions:Issue and Implication: Whether the product from an ANDA filer must have the same packaging configuration in order to be “A” rated.
Action Requested by…Read more
Product: Belviq®(lorcaserin) and Bacitracin
Company: Eisai and others
Petition Filer: Public Citizen
Petition Number(s): 2021P-0378
Date of Petition: April 13, 2021
Responding Petitions:Issue and Implication: Whether current FDA practice regarding products removed from the market for safety reasons is sufficient to ensure…Read more
Product: Sutab®(magnesium sulfate et al) Tablets and other tablet colonoscopy preps
Company: Braintree
Petition Filer: Braintree
Petition Number(s): 2021P-0376
Date of Petition: April 13, 2021
Responding Petitions:Issue and Implication: Whether current approval standards for NDAs and ANDAs is sufficient to ensure efficacy of…Read more
Login
Latest updates
Product: Lexiscan®(regadenoson) Injection
Company: Astellas
Petition Filer: IDRS Labs
Petition Number(s): 2021P-0389
Date of Petition: April 15, 2021
Responding Petitions:Issue and Implication: Whether the product from an ANDA filer must have the same packaging configuration in order to be “A” rated.
Action Requested by…Read more
Product: Belviq®(lorcaserin) and Bacitracin
Company: Eisai and others
Petition Filer: Public Citizen
Petition Number(s): 2021P-0378
Date of Petition: April 13, 2021
Responding Petitions:Issue and Implication: Whether current FDA practice regarding products removed from the market for safety reasons is sufficient to ensure…Read more
Product: Sutab®(magnesium sulfate et al) Tablets and other tablet colonoscopy preps
Company: Braintree
Petition Filer: Braintree
Petition Number(s): 2021P-0376
Date of Petition: April 13, 2021
Responding Petitions:Issue and Implication: Whether current approval standards for NDAs and ANDAs is sufficient to ensure efficacy of…Read more
Login
Search Forums
Latest updates
Product: Lexiscan®(regadenoson) Injection
Company: Astellas
Petition Filer: IDRS Labs
Petition Number(s): 2021P-0389
Date of Petition: April 15, 2021
Responding Petitions:Issue and Implication: Whether the product from an ANDA filer must have the same packaging configuration in order to be “A” rated.
Action Requested by…Read more
Product: Belviq®(lorcaserin) and Bacitracin
Company: Eisai and others
Petition Filer: Public Citizen
Petition Number(s): 2021P-0378
Date of Petition: April 13, 2021
Responding Petitions:Issue and Implication: Whether current FDA practice regarding products removed from the market for safety reasons is sufficient to ensure…Read more
Product: Sutab®(magnesium sulfate et al) Tablets and other tablet colonoscopy preps
Company: Braintree
Petition Filer: Braintree
Petition Number(s): 2021P-0376
Date of Petition: April 13, 2021
Responding Petitions:Issue and Implication: Whether current approval standards for NDAs and ANDAs is sufficient to ensure efficacy of…Read more