Drug Approval | 28 December 2024
Shilpa Medicare's Unit IV receives Eurasia GMP approval
Both units of Shilpa Medicare (Unit IV and Unit VII), have now received GMP approval from Eurasia
Both units of Shilpa Medicare (Unit IV and Unit VII), have now received GMP approval from Eurasia
GEMTESA is the first and only beta-3 agonist approved for the treatment of men with OAB symptoms who are receiving pharmacological therapy for BPH
This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP
Divalproex Sodium Delayed-Release Capsules USP, 125 mg have an estimated market size of US$ 61.1 million for twelve months ending September 2024 according to IQVIA
FDC Ltd has received final approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets
The company will receive GMP compliance certificate which will further help to accelerate the business growth across the globe
Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the
Lidocaine and Prilocaine cream had annual sales of US $22.05 million in the United States (IQVIA MAT October 2024)
Difluprednate Ophthalmic Emulsion, 0.05% is a topical corticosteroid that is indicated in the treatment of inflammation and pain associated with ocular surgery
The TGA approval marks a pivotal step in Rusan Pharma’s expansion into the Australian market
An investigational long-acting monoclonal antibody designed to protect infants from RSV disease during their first RSV season
Final decision from the European Commission is anticipated within the coming months
Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells
This product is indicated in coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity.
The successful completion of RRA assessment by the USFDA, would enable company to open up its business in the USA market
The fixed-dose combination of Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen
Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients
For people with relapsed or refractory diffuse large B-cell lymphoma
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander
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