Generic Launches

Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date

Spring 2015

GENERICally Speaking
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

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