Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Docosanol
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Aleor Dermaceuticals Receives Final USFDA Approval for Cold Sore Drug
Details : Docosanol is a drug used for topical treatment for recurrent herpes simplex labialis episodes, inhibits fusion between plasma membrane and herpes simplex virus envelope, thereby preventing viral entry into cells and subsequent viral replication.
Brand Name : Docosanol-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 04, 2022
Lead Product(s) : Docosanol
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Nystatin,Triamcinolone Acetonide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Recipient : Alembic Pharmaceuticals Limited
Deal Size : Not Applicable
Deal Type : Not Applicable
Alembic Pharmaceuticals' JV Gets USFDA Final Nod for Anti-Fungal Drug
Details : The approved ANDA is therapeutically equivalent to the reference-listed drug product Nystatin and Triamcinolone Acetonide ointment, of strength 100,000 units/gram, used for the treatment of cutaneous candidiasis.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 08, 2022
Lead Product(s) : Nystatin,Triamcinolone Acetonide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Recipient : Alembic Pharmaceuticals Limited
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Mupirocin
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Sponsor : Alembic Pharmaceuticals Limited
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Mupirocin cream USP, 2% is indicated for the treatment of secondarily infected traumatic skin lesions due to susceptible strains of S. aureus and S. pyogenes.
Brand Name : Mupirocin
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 17, 2021
Lead Product(s) : Mupirocin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Sponsor : Alembic Pharmaceuticals Limited
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Metronidazole
Therapeutic Area : Dermatology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Aleor Dermaceuticals Receives US FDA Approval for Metrogel Gel
Details : Aleor Dermaceuticals has received final approval from the US FDA for its Abbreviated New Drug Application for metronidazole gel USP, 1%. The ANDA is therapeutically equivalent to the reference listed drug product (RLD), Metrogel gel, 1%, of Galderma Labo...
Brand Name : Metrogel
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 06, 2021
Lead Product(s) : Metronidazole
Therapeutic Area : Dermatology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Efinaconazole
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Efinaconazole Topical Solution, 10% is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 08, 2021
Lead Product(s) : Efinaconazole
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Nystatin,Triamcinolone Acetonide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram, of Taro Pharmaceuticals U.S.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 01, 2021
Lead Product(s) : Nystatin,Triamcinolone Acetonide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Testosterone
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Testosterone gel, 1.62% (20.25 mg/1.25 gm actuation) is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism and Hypogonadotropic hypogonadism.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 25, 2020
Lead Product(s) : Testosterone
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tavaborole
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Aleor Dermaceuticals Receives USFA Tentative Approval for Antifungal Medication
Details : Aleor Dermaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tavaborole Topical Solution, 5%.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 13, 2020
Lead Product(s) : Tavaborole
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Clobetasol Propionate
Therapeutic Area : Dermatology
Study Phase : Approved
Recipient : Alembic Pharmaceuticals Limited
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The approved ANDA is therapeutically equivalent to the reference listed drug product, Clobex Shampoo, of Galderma Laboratories, Clobetasol Propionate Shampoo is indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 yea...
Brand Name : Clobetasol Propionate-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 20, 2020
Lead Product(s) : Clobetasol Propionate
Therapeutic Area : Dermatology
Highest Development Status : Approved
Recipient : Alembic Pharmaceuticals Limited
Deal Size : Not Applicable
Deal Type : Not Applicable
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