Lead Product(s) : Aspirin,Inapplicable
Therapeutic Area : Undisclosed
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Contrary to previous findings, low-dose aspirin therapy before conception and during early pregnancy may increase pregnancy chances and live births among women who have experienced one or two prior miscarriages.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 25, 2021
Lead Product(s) : Aspirin,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Tacrolimus,Inapplicable
Therapeutic Area : Undisclosed
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Glenmark Pharmaceuticals Receives ANDA Approval for Tacrolimus Capsules USP, 0.5 mg, 1 mg and 5 mg
Details : Glenmark has been granted final approval by the U.S. FDA for TacrolimusCapsules USP, 0.5 mg, 1 mg and 5 mg, the generic version of Prograf®1 Capsules, 0.5 mg, 1 mg and 5 mg, of Astellas Pharm US.
Product Name : Prograf
Product Type : Antibiotic
Upfront Cash : Inapplicable
November 11, 2020
Lead Product(s) : Tacrolimus,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sirolimus,Inapplicable
Therapeutic Area : Undisclosed
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Glenmark Pharmaceuticals Receives ANDA Approval for Sirolimus Tablets, 0.5 mg, 1 mg and 2 mg
Details : Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) for Sirolimus Tablets, 0.5 mg, 1 mg and 2 mg, the generic version of Rapamune Tablets, 0.5 mg, 1 mg and 2 mg, of PF Prism CV.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
October 19, 2020
Lead Product(s) : Sirolimus,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dexmedetomidine Hydrochloride,Inapplicable
Therapeutic Area : Undisclosed
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Aurobindo Pharma Receives US FDA Approval for Generic Precedex
Details : Aurobindo's dexmedetomidine HCl in 0.9% sodium chloride injection is a therapeutic equivalent generic version of Hospira's Precedex in 0.9% sodium chloride injection.
Product Name : Dexmedetomidine Hydrochloride-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 12, 2020
Lead Product(s) : Dexmedetomidine Hydrochloride,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Mycophenolate Mofetil,Inapplicable
Therapeutic Area : Undisclosed
Study Phase : Approved FDF
Sponsor : F. Hoffmann-La Roche
Deal Size : Undisclosed
Deal Type : Agreement
Details : Entero will be responsible for promotion, marketing and distribution of Roche Pharma’s key nephrology drugs viz., Mycophenolate Mofetil (Cellcept), Valganciclovir (Valcyte), Epoetin Beta (NeoRecormon), and Methoxy Polyethylene Glycol-epoetin Beta (Mirc...
Product Name : Cellcept
Product Type : Antibiotic
Upfront Cash : Undisclosed
June 18, 2020
Lead Product(s) : Mycophenolate Mofetil,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Approved FDF
Sponsor : F. Hoffmann-La Roche
Deal Size : Undisclosed
Deal Type : Agreement