Drug Approval | 28 August 2023
Briefs: Granules India
Granules India received approval from Brazilian Health Regulatory Agency ANVISA
Granules India received approval from Brazilian Health Regulatory Agency ANVISA
This product will be manufactured at Lupin's Pithampur facility in India
Zinc Sulfate Injection is indicated in adult and paediatric patients as a source of zinc for parenteral nutrition
First PARP inhibitor approved in Japan to demonstrate clinically meaningful benefits in combination with a new hormonal agent
The drug will be manufactured at JB Pharma's formulation manufacturing facility in Panoli, Gujarat
Oteseconazole Capsules were found to be safe and more effective than fluconazole
LEO Pharma is developing delgocitinib cream for the treatment of moderate to severe chronic hand eczema, a hard-to-treat disease where there is a high unmet medical need for treatment
Glenmark's current portfolio consists of 184 products authorized for distribution in the U.S. marketplace
The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.
Doxycycline Hyclate Delayed-Release Tablets USP (RLD Doryx ) had estimated annual sales of USD 9 million in the U.S. (IQVIA MAT June 2023).
ELREXFIO’s label contains a boxed warning for cytokine release syndrome and neurologic toxicity
Senvelgo is the first liquid once-daily, orally administered prescription medication to improve glycemic control in cats with diabetes mellitus
This is the 166th ANDA out of Eugia Pharma Speciality Group facilities
The inspection was conducted at its Goa, Vema manufacturing facility
Fluocinolone Acetonide Oil (RLD Derma-Smoothe/FS®) had estimated annual sales of USD 10 million in the U.S. (IQVIA MAT June 2023)
The inspection closed with zero observations and a classification of No Action Indicated
The product is being launched in August 2023
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