Sun Pharma gets USFDA filing acceptance of new drug application for Deuruxolitinib

The NDA filing for deuruxolitinib with the U.S. FDA is based on two pivotal Phase III trials

Biocon Biologics gets complete response letter from USFDA for Biosimilar Insulin Aspart

The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022

Zydus receives final approval from the USFDA for Sugammadex Single-Dose Vial

Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide

Lupin receives tentative approval from USFDA for Tolvaptan Tablets

Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)

Asahi Kasei Pharma files application for approval to manufacture and sell Cresemba Capsule

The product is an additional formulation of Cresemba Capsule 100 mg and Cresemba Intravenous Infusion 200 mg

Marksans Pharma gets USFDA approval for Esomeprazole Magnesium delayed-release capsules

This product is bioequivalent to the reference listed drug (RLD), Nexium 24 HR Delayed- Release Capsules, 2.0mg (OTC), of AstraZeneca Pharmaceuticals

Strides receives USFDA approval for Efavirenz, Emtricitabine & Tenofovir Disoproxil Fumurate tablets

The approval adds to a list of products that Strides has approved in this therapeutic category through the PEPFAR pathway taking the total to 15 products

Alembic received 6 USFDA approvals during Q2FY24

The company has received six final approvals that includes Chlorpromazine Hydrochloride Tablets

Strides receives USFDA approval for Icosapent Ethyl capsules

The product is bioequivalent and therapeutically equivalent to the RLD, Vascepa of Amarin

Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility

The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated

USFDA delegation visits Divi's Laboratories’ Unit I at Choutuppal, Telangana

The delegation's visit covered a wide range of topics

USFDA inspection at Piramal Pharma’s Bethlehem facility

GeoVax secures multi-product license for ProBioGen's AGE1.CR.pIX suspension cell line

The AGE1.CR.pIX cell line's versatility allows it to support a wide range of viruses and vaccine types

Strides receives USFDA approval for Icosapent Ethyl Capsules

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD)

Dishman Carbogen Amcis updates on inspection by EDQM and AIFA

The company's Bavla site was successfully jointly inspected by the EDQM and Italian Medicines Agency (AIFA)

Biocon Biologics receives European Commission approval for biosimilar of Aflibercept ‘Yesafili’

The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway

Zydus receives final approval from the USFDA for Clindamycin Phosphate Gel USP, 1%

Clindamycin Phosphate Gel is used to treat acne

USFDA conducts inspection at InvaGen manufacturing facility in Central Islip, NY, USA

InvaGen has received 5 inspectional observations in Form 483

Briefs: Caplin Steriles, Zydus and APL Healthcare

Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients

Ojjaara approved in the US as the first and only treatment for myelofibrosis patients with anaemia

Approval is for use in myelofibrosis patients with anaemia regardless of prior myelofibrosis therapy