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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.
Lead Product(s): Docosanol
Therapeutic Area: Infections and Infectious Diseases Product Name: Docosanol-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 04, 2022
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.
Lead Product(s): Nystatin,Triamcinolone Acetonide
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Alembic Pharmaceuticals Limited
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 08, 2022
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.
Lead Product(s): Mupirocin
Therapeutic Area: Infections and Infectious Diseases Product Name: Mupirocin
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alembic Pharmaceuticals Limited
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2021
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 Laboratories LP.
Lead Product(s): Metronidazole
Therapeutic Area: Dermatology Product Name: Metrogel
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 06, 2021
Details:
Efinaconazole Topical Solution, 10% is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.
Lead Product(s): Efinaconazole
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2021
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.
Lead Product(s): Nystatin,Triamcinolone Acetonide
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2021
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.
Lead Product(s): Testosterone
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 25, 2020
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%.
Lead Product(s): Tavaborole
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 13, 2020
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 years of age and older.
Lead Product(s): Clobetasol Propionate
Therapeutic Area: Dermatology Product Name: Clobetasol Propionate-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Alembic Pharmaceuticals Limited
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 20, 2020
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