Drug Approval | April 27, 2023
Ipca Laboratories gets 3 observations for Piparia, Silvassa unit
The company will submit its comprehensive response on these observations to the US FDA within the stipulated time
The company will submit its comprehensive response on these observations to the US FDA within the stipulated time
Aji Bio-Pharma has six fill finish lines located in San Diego, including a new line
Study efficacy measures will include the expression of dystrophin protein and motor function.
Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression
FDA’s NME approvals declined substantially in 2022, causing overall New Drug Application (NDA) approvals to drop
Gabapentin Tablets are indicated for management of postherpetic neuralgia in adults
The company is addressing these observations
With the combination of oral solid, inhalation, dermatology, high potent and oral contraceptive products, this is an important facility of the company
The data from this study show that MM-II has the potential to provide durable pain relief for our patients
The audit is a pre-approval inspection for three products filed from the facility
Subscribe To Our Newsletter & Stay Updated
