Generic Launches

Spring 2016

GENERICally Speaking
Reference Listed Drug NDA Holder Generic Drug Name ANDA
Indication Launch Date
Ortho-Tri-Cyclen Lo Janssen Norgestimate / Ethinyl Estradiol Mylan used by women to prevent pregnancy 1/5/2016
Ortho-Tri-Cyclen Lo Janssen  Norgestimate / Ethinyl Estradiol Teva used by women to prevent pregnancy 1/5/2016
Ortho-Tri-Cyclen Lo Janssen Norgestimate / Ethinyl Estradiol Lupin  used by women to prevent pregnancy 1/6/2016
Felbatol Meda Felbamate Mylan monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children 1/19/2016
Gleevec Novartis AG Imatinib Mesylate Sun Pharms Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase; myelodysplastic/myeloproliferative diseases (MDS/MPD); aggressive systemic mastocytosis; (ASM); hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) 2/1/2016
Glumetza HCI ER Santarus Metformin Hydrochloride ER Lupin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus 2/2/2016
Pulmicort Respules AstraZeneca Budesonide Inhalation Suspension Teva indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age 3/9/2016
Campral Merck Acamprosate Calcium DR Teva used for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at the start of treatment 3/22/2016
Intermezzo Purdue Pharma Zolpidem Tartrate Lupin  indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep 3/22/2016
Voltaren Gel Novartis Diclofenac Sodium Topical Gel 1% Amneal non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as knees and those of the hands 3/24/2016
Nasonex Merck Mometasone Furoate Monohydrate Apotex indicated for treatment of nasal congestion 3/24/2016
Ultram ER Valeant Tramadol Hydrochloride ER Mylan indicated for management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time 3/28/2016
Aricept Eisai Donepezil Hydrochloride Lupin indicated for treatment of dementia of the Alzheimer's type 3/31/2016
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