Abbreviated New Drug Applications and 505(b)(2) Applications
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications.
| Reference Listed Drug | ANDA Holder | Generic Drug Name | ANDA Applicant(s) |
Indication | Launch Date |
|---|---|---|---|---|---|
| Oracea | Galderma | doxycycline | Lupin | Used for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. | 4/9/2024 |
| Fleqsuvy | Azurity | baclofen | ANI | Used for the treatment of pain and certain types of spasticity (muscle stiffness and tightness) from multiple sclerosis, spinal cord injuries, or other spinal cord diseases. | 4/9/2024 |
| Toviaz | Hetero | fesoterodine fumerate | Camber | Used for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. | 4/17/2024 |
| Myrbetriq ER | Astellas | mirabegron | Lupin | Used for the treatment of overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. | 4/20/2024 |
| Myrbetriq ER | Astellas | mirabegron | Zydus | Used for the treatment of overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. | 4/22/2024 |
| EstroGel | Ascend | estradiol | Solaris | Used for the treatment of moderate to severe vasomotor symptoms due to menopause, and for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. | 4/25/2024 |
| Abilify OS | Bristol-Myers Squibb | aripiprazole | Camber | Used for the treatment of schizophrenia, Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, Irritability Associated with Autistic Disorder, Treatment of Tourette’s Disorder | 4/26/2024 |
| Cupric Chloride | Hospira | cupric chloride | Somerset Therapeutics | Used as a supplement to intravenous solutions given for TPN. Administration helps to maintain copper serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms. | 5/1/2024 |
| Viibryd | AbbVie | vilazodone | Apotex | Used for the treatment of major depressive disorder (MDD). | 5/2/2024 |
| Oracea | Galderma | doxycycline | Dr. Reddy's Labs | Used for the treatment of bacterial infections, including acne, rosacea, urinary and respiratory tract infections, eye infections, gum disease, gonorrhea, chlamydia, and syphilis. Doxycycline can also be used to prevent malaria and treat infections caused by mites, ticks, or lice. | 5/3/2024 |
| Cialis | Eli Lilly | tadalafil | TWi | Used for the treatment of erectile dysfunction (ED, impotence; inability to get or keep an erection), and the symptoms of benign prostatic hyperplasia (BPH; an enlarged prostate) which include difficulty urinating (hesitation, dribbling, weak stream, and incomplete bladder emptying), painful urination, and urinary frequency and urgency in adult men. | 5/6/2024 |
| Halaven | Eisai | eribulin | Apotex | Used for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. | 5/7/2024 |
| Esbriet | Genentech | pirfenidone | Apotex | Used for the treatment of idiopathic pulmonary fibrosis (IPF). | 5/8/2024 |
| Cetrotide | Merck | cetrorelix | Apotex | Used for the prevention of premature ovulation in women undergoing controlled ovarian stimulation therapy followed by oocyte retrieval and assisted reproductive technology. | 5/14/2024 |
| Narcan | Emergent | naloxone | Walgreens | Used for the reversal of an opioid overdose or suspected opioid overdose: it is intended for immediate administration as emergency therapy in settings where opioids may be present | 5/15/2024 |
| Banzel | Eisai | rufinamide | Camber | Used for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults. | 5/16/2024 |
| Norepinephrine Bitartrate | Long Grove | norepinephrine bitartrate | Long Grove | Used for to raise blood pressure in adult patients with severe, acute hypotension, and it is one of the most commonly used injectable medications in the critical care setting. | 5/22/2024 |
| Vibramycin | Pfizer | doxycycline | Lupin | Used for to reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline and other antibacterial drugs. | 6/3/2024 |
| Sodium Acetate | Hospira | sodium acetate | Hikma | Used for as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. | 7/11/2024 |
