505(b)(2) – Q2 2024 approvals

505(b)(2) – Q2 2024 approvals

1. CHEWTADZY (Tadalafil), Chewable tablet

Approval: Jun. 28, 2024

Applicant: B Better LLC

Indication: Erectile Dysfunction & Benign Prostatic Hyperplasia

PREA: Waived, because necessary studies are impossible or highly impracticable

Value addition: Alternate (Chewable) dosage form

 

2. PEMETREXED (Pemetrexed), Injection

Approval: Jun. 25, 2024

Applicant: Apotex

Indication: NSCLC & Pleural mesothelioma

PREA: Exempted, none of the PREA criteria apply to the application

Value addition: Different salt

 

3. TEPYLUTE (Thiotepa), Injection

Approval: Jun. 25, 2024

Applicant: Shorla Oncology

Indication: adenocarcinoma of the breast or ovary

PREA: Waived because necessary studies are impossible or highly impracticable

Value addition: Ready-to-dilute formulation which eliminates the need for complex and time-consuming reconstitution

 

4. VIGAFYDE (Vigabatrin), Oral solution

Approval: Jun. 17, 2024

Applicant: Pyros Pharms

Indication: infantile spasms in pediatric patients 1 month to 2 years of age

PREA: Exempted, this drug product for this indication has an orphan drug designation

Value addition: First and Only Ready-to-Use Vigabatrin Oral Solution

 

5. TERIPARATIDE (teriparatide), SC injection

Approval: Jun. 4, 2024

Applicant: Almaject

Indication: Osteoporosis

PREA: Exempted, none of PREA criteria apply here.

Value addition: The first FDA-approved teriparatide alternative for Forteo®

 

6. ONYDA XR (CLONIDINE HCl), Oral extended-release suspension

Approval: May 24, 2024

Applicant: Tris Pharma

Indication: Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 years of age and older

PREA: Waived for 0 to 4 years because necessary studies are impossible or highly impracticable AND deferred for 4 years to younger than 6 years of age

Value addition: Once-a-day extended-release oral suspension with nighttime dosing, and the first and only liquid nonstimulant ADHD medication approved in the US.

 

7. MYHIBBIN (Mycophenolate Mofetil), Oral suspension

Approval: May 1, 2024

Applicant: Azurity Pharmaceuticals

Indication: Prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older

PREA: Product is appropriately labeled for use in patients, no additional studies are needed

Value addition: Only ready-to-use mycophenolate mofetil oral suspension

 

8. LIBERVANT (Diazepam), Buccal film

Approval: Apr 26, 2024

Applicant: Aquestive Therapeutics

Indication: Intermittent, stereotypic episodes of frequent seizure activity in patients with epilepsy 2 to 5 years of age

PREA: Exempted, because of an orphan drug designation

Value addition: First and only FDA approved orally administered rescue product for the treatment of seizure clusters in patients ages 2 to 5. It provides a new way to deliver diazepam.

 

9. RINVOQ LQ (Upadacitinib), Oral solution

Approval: Apr 26, 2024

Applicant: Abbvie

Indication: Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis & psoriatic arthritis

PREA: Exempted, because of an orphan drug designation

Value addition: Pediatric friendly formulation

 

10. VIJOICE (Alpelisib), Oral granules

Approval: Apr 24, 2024

Applicant: Novartis

Indication: adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS)

PREA: Exempted, because of an orphan drug designation

Value addition: Pediatric friendly formulation

 

11. PIVYA (Pivmecillinam), Tablet

Approval: Apr 24, 2024

Applicant: Utility Therapeutics Ltd

Indication: Uncomplicated urinary tract infection in female patients 18 years of age and older

PREA: Deferred as PMR for 2 months to less than 18 years. Waived for birth to less than 2 months as studies are impossible.

Value addition: Prodrug of mecillinam. Due to its unique MOA & stability against ╬▓-lactamase, it may address antibiotic resistance issues.

 

12 LUMIFY PRESERVATIVE FREE (Brimonidine Tartarate), Ophthalmic drops

Approval: Apr 19, 2024

Applicant: Bausch & Lamb

Indication: Relief of redness of the eye due to minor eye irritations

PREA: Exempted because none of the PREA criteria apply

Value addition: Preservative free OTC product

 

13. REZENOPY (Naloxone HCl), Nasal Spray

Approval: Apr. 19, 2024

Applicant: Summit Bioscience

Indication: Emergency treatment of known or suspected opioid overdose

PREA: Not required. This product is appropriately labelled for use in all relevant pediatric populations.

Value addition: Rezenopy is a high dose formulation containing 10 mg of naloxone per spray.

 

14. ENTRESTO SPRINKLE (Sacubitril + Valsartan), pellets capsules

Approval: Apr 12, 2024

Applicant: Novartis

Indication: Adult & Pediatric Heart Failure

PREA: Fulfilled pediatric study requirements for ages 1 month to less than 18 years of age. Waived for birth to less than 1 month of age because studies are impossible or highly impractical.

Value addition: Pediatric friendly formulation

 

15. RETEVMO (Selpercatinib), tablet

Approval: Apr. 10, 2024

Applicant: Loxo Onco / Eli Lilly

Indication: Non-Small Cell Lung Cancer; Thyroid Cancer; Solid tumors

PREA: Exempted because of orphan drug designation

Value addition: Tablet dosage forms with additional strengths

 

16. XROMI (Hydroxyurea), Oral solution

Approval: Apr 04, 2024

Applicant: Nova Labs

Indication: sickle cell anemia with recurrent moderate to severe painful crises in pediatric patients aged 6 months of age to less than 2 years

PREA: Exempted because of orphan drug designation

Value addition: First oral liquid formulation for pediatric patients

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