Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date
| Reference Listed Drug | NDA Holder | Generic Drug Name | ANDA Applicant(s) |
Indication | Launch Date |
|---|---|---|---|---|---|
| Diovan | Novartis | valsartan tablets | Mylan | treatment of hypertension | 1/5/2015 |
| Diovan | Novartis | valsartan tablets | Lupin Pharms. | treatment of hypertension | 1/6/2015 |
| Diovan | Novartis | valsartan tablets | Teva | treatment of hypertension | 1/6/2015 |
| Clobex | Galderma Labs. | clobetasol propionate spray | Perrigo | topical treatment of moderate to severe plaque psoriasis | 1/12/2015 |
| AndroGel 1.0% | AbbVie | AB therapeutic equivalent testosterone gel 1.0% | Perrigo | treat adult males who have low or no testosterone | 1/12/2015 |
| Colcrys | Takeda Pharms. America | colchicine tablets | Prasco |
prophylaxis and treatment of acute gout flares in adults,
and the treatment of familial Mediterranean fever
(FMF) in adults and children age 4 or older
|
1/12/2015 |
| Epivir-HBV | GlaxoSmithKline | lamivudine tablets | Mylan |
treatment of chronic hepatitis B virus infection
associated with evidence of hepatitis B
viral replication and active liver inflammation
|
1/15/2015 |
| Vancocin | ANI Pharms. | vancomycin hydrochloride capsules | Lupin |
treatment of C. difficile-
associated diarrhea and enterocolitis
caused by Staphylococcus aureus
(including methicillin-resistant strains)
|
2/2/2015 |
| Pulmicort Respules | AstraZeneca | budesonide inhalation suspension | Actavis |
control and prevent asthma symptoms in children
ages 12 months to 8 years
|
2/9/2015 |
| Lovenox | Sanofi Aventis | enoxaparin sodium injection | Teva (and Chemi SPA) |
prophylaxis of deep vein thrombosis (DVT)
in patients undergoing abdominal surgery,
hip or knee replacement surgery,
or in the medical patients with severely
restricted mobility during acute illness;
and also for the treatment of acute DVT
|
2/17/2015 |
| Zyvox | Pharmacia and Upjohn | linezolid injection | Teva (and Chemi SPA) | treatment of infections caused by Gram-positive bacteria | 2/17/2015 |
| Subutex | Reckitt Benckiser | buprenorphine tablets | Actavis | treatment of opioid dependence | 2/20/2015 |
| Lumigan | Allergan | bimatoprost ophthalmic solution, 0.03% | Lupin |
reduction of elevated intraocular
pressure in patients with open
angle glaucoma or ocular hypertension
|
2/23/2015 |
| Seasonique | Teva Women's Health | levonorgestrel / ethinyl estradiol and ethinyl estradiol extended-cycle oral contraceptive tablets | Glenmark Generics | use by women to prevent pregnancy | 2/25/2015 |
| Tarka | AbbVie | trandolapril / verapamil hydrochloride extended-release tablets | Glenmark Generics | treatment of hypertension | 2/26/2015 |
| Temovate | Fougera | clobetasol cream 0.05% | Actavis |
relief of the inflammatory and pruritic
manifestations of corticosteroid-responsive
dermatoses
|
3/9/2015 |
| Antabuse | Odyssey Pharm. | disulfiram tablets | Mylan |
aid in management of selected
chronic alcohol patients who want to remain
in a state of enforced sobriety
|
3/11/2015 |
| Subutex | Reckitt Benckiser | buprenorphine hydrochloride sublingual tablets | Mylan |
treatment of opioid dependence and is
preferred for induction
|
3/11/2015 |
| Exforge | Novartis | amlodipine / valsartan tablets | Mylan |
treatment of hypertension, to lower blood pressure:
in patients not adequately controlled on monotherapy
with DHP CCB or an ARB; as initial therapy in
patients likely to need multiple drugs to achieve
their blood pressure goals
|
3/31/2015 |
| Exforge | Novartis | amlodipine / valsartan tablets | Sandoz |
treatment of hypertension, to lower blood pressure:
in patients not adequately controlled on monotherapy
with DHP CCB or an ARB; as initial therapy in
patients likely to need multiple drugs to achieve
their blood pressure goals
|
3/31/2015 |
| Exforge | Novartis | amlodipine / valsartan tablets | Teva |
treatment of hypertension, to lower blood pressure:
in patients not adequately controlled on monotherapy
with DHP CCB or an ARB; as initial therapy in
patients likely to need multiple drugs to achieve
their blood pressure goals
|
3/31/2015 |
