Pfizer has received an approvable letter from the FDA for its antibiotic dalbavancin HCl, which is used to treat adults with complicated skin and skin structure infections, including those caused by methicillin-resistant staphylococcus aureus (MRSA).
The letter cited deviations from current good manufacturing practices at a third-party manufacturer “not specifically related to dalbavancin,” according to Pfizer, which said the third-party manufacturer is working with the FDA to resolve the problems.
The FDA recently published a draft guidance on studies designed to show noninferiority as a basis for approval of antibacterial drug products. The agency has requested that Pfizer provide additional data in this regard concerning dalbavancin. Pfizer said it is working with the FDA to respond to these new requirements and is addressing a question regarding the length of storage time following reconstitution of the drug.