Briefs: Alembic Pharmaceuticals and Veerhealth Care
The successful completion of RRA assessment by the USFDA, would enable company to open up its business in the USA market
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
Sitagliptin and Metformin Hydrochloride Tablets, 50 mg/500 mg and 50 mg/1000 mg are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xalatan
If approved, Blenrep (belantamab mafodotin) in combinations with BorDex (BVd) and PomDex (BPd) could redefine multiple myeloma treatment at or after first relapse
HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors
The product will be manufactured at Lupin’s Somerset facility in the US
Octreotide is synthetic peptide manufactured by Shilpa Pharma Lifesciences through solid phase synthesis
Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years
Aromatic L-amino acid decarboxylase deficiency is a rare genetic disorder that affects the production of some neurotransmitters
Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
This product will be manufactured at Lupin’s Nagpur facility in India
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature
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