US FDA classifies Biocon Biologics site as VAI
The VAI classification was given to Biocon Biologics’ Insulins facilities in Johor Bahru, Malaysia
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USFDA
Zydus signs agreement with CVS Caremark to add Zituvio, Zituvimet and Zituvimet XR (Sitagliptin |…
CVS Caremark added Zydus’ Zituvio and combination products to its template formulary starting January 1, 2025
USFDA approves injectable version of Bristol Myers Squibb’s Opdivo
The approval includes indications for renal cell carcinoma, melanoma, non-small cell lung cancer, head and neck squamous cell…
USFDA restricts imports of 11 Viatris drugs made in Indore facility
It makes exceptions, subject to certain conditions, for four products based on shortage concerns
Biocon receives EIR with VAI status
This is based on a surveillance inspection conducted by the USFDA between September 23-27, 2024
Lupin gains tentative USFDA nod for Sitagliptin and Metformin Hydrochloride Tablets
Sitagliptin and Metformin Hydrochloride tablets to market a generic equivalent of Janumet tablets of Merck Sharp & Dohme
BridgeBio’s drug for ATTR-CM gains US FDA approval
BridgeBio plans to price the therapy at $18,759.12 for a 28-day supply
Alembic Pharma gets form 483 with five procedural observations by USFDA
The GMP inspection was conducted at the company’s Jarod facility
Alembic Pharma gains USFDA final approval for Ivabradine Tablets, 5 mg and 7.5 mg
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Corlanor Tablets, 5 mg and 7.5 mg, of…
Cipla’s manufacturing facility in Goa gets VAI classification
The US FDA conducted a cGMP inspection between June 10-21, 2024