OxemiaTM (Desidustat) is an oral tablet formulation that is the first-in-India alternative to injectable erythropoietin-stimulating agents (ESAs)
The breakthrough approval expands the existing indication of Jardiance to include adults with heart failure with preserved ejection fraction (HFpEF), an underserved patient population that previously had no approved therapies in Europe
NATCO and Teva are launching these strengths of lenalidomide pursuant to a license of patents owned by Celgene
The approval marks the first-and-only immunotherapy-based treatment for use before surgery for non-small cell lung cancer
Novel technology combines ACUVUE daily disposable contact lenses with an established antihistamine in FDA- first in its new category
The product will be manufactured at Lupin’s facility in Pithampur, India
TruPharma has commenced commercial marketing of Sage's approved generic cartridge product
First of three Amneal biosimilars expected for U.S. approval and launch in 2022
Sevelamer Hydrochloride tablets, 800 mg is a generic equivalent of Renagel tablets, 800 mg
Vonjo is the first approved therapy to specifically address the needs of adult cytopenic myelofibrosis patients
The sNDA was supported by the clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva in adult patients with relapsed or refractory B cell non-hodgkin lymphoma in China
Divalproex Sodium Extended-Release tablets are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, as monotherapy and adjunctive therapy and prophylaxis of migraine headaches
In a European work-sharing procedure (WSP), Glucophage was approved as the first oral anti-diabetic medication to be used safely from conception to birth
Keytruda plus Lenvima is also approved in the U.S. and Europe for the first-line treatment of adult patients with advanced RCC.
Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death or hospitalization for heart failure, regardless of ejection fraction
The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad
Therapeutic use of the product is for short term symptomatic relief of colds, chills and influenza including chesty coughs
To be marketed by Strides Pharma Inc. in the US market
Since the beginning of the pandemic, more than one million patients with severe COVID-19 have been treated with Actemra/RoActemra
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