Dr. Reddy’s Laboratories, Inc.: AVT03

Section 505-1 of the Food, Drug, and Cosmetic Act (FDCA) authorizes FDA to require the submission of a risk evaluation and mitigation strategy (REMS), if FDA determines that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks [section 505-1(a)].

The REMS, should it be approved, will create enforceable obligations.

The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA 483 prior to your complete response to your application.

Your complete response should include the date(s) of the facility's response to the FDA Form 483. The assessment of application approvability and the resolution of inspection deficiencies would be evaluated upon receipt of the complete response and may include re-inspection of the facility.

Cosmetic Act for Cyclophosphamide Injection, 500 mg/mL, | gm/2mL and 2 gm/4mL.

Please refer to your New Drug Application (NDA) dated and received September 14, 2015, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Xeglyze (abametapir) Lotion, 0.74%.

Cosmetic Act (FDCA) for bortezomib for injection 3.5 mg/vial.

Therefore, the changes to the batch formula and manufacturing process may have impacted the quality of the drug product and it may not be possible to bridge the stability data submitted for batches EH12023, EH12024, and EH13001. Provide the following to address concerns that changes to the batch formula and manufacturing process have not adversely impacted the drug product quality:

To facilitate our review of the biowaiver request for the intravenous administration of the proposed Bortezomib for Injection (3.5 mg/vial), provide a table comparing side-by-side the physico-chemical properties of the exhibit batch(es) produced using the final proposed commercial manufacturing process at the time of batch release and during long-term stability testing versus the Listed Drug.

If applicable, provide justification for why you believe that any observed differences in the physico-chemical characteristics of the final test and the reference products would not impact usability, bioavailability, as well as efficacy of the drug product.

NDA 206927 provides for the use of bortezomib for injection 3.5 mg/vial for the following indications wo)

1. Your application referenced the Drug Master File (DMF) 23996. This DMF was found inadequate to support your submission and a deficiency letter was sent to the DMF holder on December 4, 2014. These deficiencies must be adequately addressed before this application can be approved.

2. The waiver request for the CFR requirement to provide data from an in vivo bioequivalence study for the intravenous route of administration cannot be granted at this time due to outstanding issues with the identity of the drug substance (refer to DMF) and the identity of the structures in the drug product and reconstituted solution.

You may resubmit the biowaiver request or alternatively you may conduct a bioequivalence study between the proposed drug product and the listed drug product for the intravenous route of administration.