CMP Development LLC: sildenafil

Federal Food, Drug, and Cosmetic Act for sildenafil oral suspension, 10 mg/ml.

Please refer to your new drug application (NDA) dated and received June 22, 2020, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for NORLIQVA (amlodipine) Oral Solution 1 mg/mL.

The FDA will communicate the outstanding issues to the facility no later than 10 business days from issuing this complete response letter.

Industry Process Validation: General Principles and Practices (2011)), rather than to develop and finalize the commercial manufacturing process.

Act for TADLIQ (Tadalafil) Oral Suspension, 4 mg/ml.

These objectionable conditions will be conveyed to the representative of the facility within 10 business days of this Complete Response Letter.

Drug, and Cosmetic Act for atorvastatin calcium oral suspension.

4. Since the application does not contain clinical efficacy and safety data for the proposed atorvastatin calcium oral suspension (proposed product), relative bioavailability results are the fundamental bridge to the efficacy and safety data of the listed drug product.

The deficiency cannot be addressed with labeling, because there is no condition of use that would ensure safety and effectiveness of the product.

Satisfactory resolution of these objectionable conditions is required (e.g., preapproval inspection and/or adequate facility responses addressing these conditions) before this application may be approved.

If it is determined that an inspection is needed to approve your application, please note that FDA continues to monitor the public health situation as well as travel restrictions.

4. Reformulate the proposed product and conduct additional relative bioavailability studies to demonstrate the bioequivalence to the listed drug or conduct a Clinical study to support the effective and safe use of the proposed atorvastatin oral suspension product.