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 | NDA Holder | Generic Drug Name | ANDA Applicant(s) |
Indication | Launch Date |
|---|---|---|---|---|---|
| Neoral | Novartis | cyclosporine | Apotex | used for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants | 1/3/2020 |
| Silenor | Currax | doxepin | Teva | used to treat insomnia characterized by difficulty with sleep maintenance | 1/3/2020 |
| NovoLog/NovoLog Mix | Novo-Nordisk | insulin aspart recombinant | N/A | used to lower blood glucose | 1/7/2020 |
| Symbicort | Astra-Zeneca | budesonide / formoterol | Prasco | used as a maintenance treatment in chronic obstructive pulmonary disease (COPD) | 1/8/2020 |
| NovoLog/NovoLog Mix | Novo-Nordisk | insulin aspart protamine | N/A | used to lower blood glucose | 1/21/2020 |
| Carafate | Allergan | sucralfate | Endo | used to treat and prevent ulcers in the intestines | 1/27/2020 |
| Clobex | Micro/Saptalis | clobetasol | N/A | used to treat psoriasis and dermatitis | 1/24/2020 |
| Absorica LD | Sun | isotretinoin | N/A | used for the management of severe recalcitrant nodular acne in patients 12 years of age and older | 2/4/2020 |
| Syprine | Bausch & Lomb | trientine HCl | Dr. Reddy's | used to treat patients with Wilson's disease who are intolerant of penicillamine | 2/7/2020 |
| Marinol | AbbVie | dronabinol | Hetero (Camber) | used to treat nausea and vomiting caused by cancer chemotherapy; also used to treat loss of appetite and weight loss in people with HIV infection | 2/11/2020 |
| Moxeza | Novartis | moxifloxacin | Lupin | used to treat conjunctivitis caused by susceptible strains of certain organisms | 2/14/2020 |
| Nexium | Astra-Zeneca | esomeprazole magnesium | Hetero (Camber) | used to treat heartburn, gastroesophageal reflux disease (GERD), stomach ulcers, and a damaged esophagus | 2/20/2020 |
| Vimovo | Horizon | naproxen / esomeprazole | Dr. Reddy's | used for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk of developing naproxen-associated gastric ulcers | 2/27/2020 |
| Vimovo | Horizon | naproxen / esomeprazole | Lupin | used for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk of developing naproxen-associated gastric ulcers | 3/5/2020 |
| Geodon | Pfizer | ziprasidone | Dr. Reddy's | used to treat occurrences of severe agitation in patients with schizophrenia | 3/17/2020 |
| Daraprim | Vyera | pyrimethamine | Dr. Reddy's | used to treat toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination | 3/20/2020 |
| Lyrica | Pfizer | pregabalin | Hetero (Camber) | used to treat pain caused by nerve damage due to diabetes or shingles infection | 3/24/2020 |
| Adderall XR | Shire | dextroamphetamine saccharate / amphetamine aspartate / dextroamphetamine sulfate / amphetamine sulfate | Lannett | used to treat Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy | 3/31/2020 |
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