Drug Approval | 04 May 2023
Indoco receives EIR for its Plant I manufacturing facility in Goa
Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.
Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.
Sun Pharma said had a teleconference call with the US Food and Drug Administration (USFDA) regarding a pulmonary embolism (serious adverse events) occurring at the 12 mg dose
It will help in bringing a significant benefit in compliance of ARV medication in the paediatric HIV treatment
The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients
Once approved, Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive lymphoma
The company will submit its comprehensive response on these observations to the US FDA within the stipulated time
Metronidazole is an antibiotic used on the skin to treat a certain skin disorder known as rosacea
Icosapent Ethyl Capsules are indicated as an adjunct to diet to reduce triglyceride levels
The USFDA had classified the inspection as "Official Action Indicated" (OAI).
This is the first time the Agency has authorized the Phase 3 clinical evaluation in the U.S of a microbiota-based live biotherapeutic based on a pooling technology
Aji Bio-Pharma has six fill finish lines located in San Diego, including a new line
Metoprolol is used with or without other medications to treat high blood pressure (hypertension).
Roflumilast reduces inflammation in the lungs that leads to chronic obstructive pulmonary disease (COPD)
Estradiol Transdermal System USP, 0.014 mg/day (weekly) had annual sales of USD 1.9 mn in the United States
Isoproterenol hydrochloride injection is indicated to improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output
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
Tavaborole Topical Solution, 5% had annual sales of US $3.1 million in the United States
Azithromycin Tablets USP, 500 mg had annual sales of US $20 million in the United States
Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.
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