RxNews® - New Generics

Provides details of recent and upcoming drug patent changes, as well as new generic product releases.

Mestinon® (pyridostigmine) — First-Time Generic

June 29, 2015 — Alvogen launched its AB-rated generic to Valeant’s Mestinon (pyridostigmine) extended-release tablets, for the treatment of myasthenia gravis.More..
Acanya® (clindamycin phosphate/benzoyl peroxide) — First-Time Generic

June 19, 2015 — The FDA approved Actavis’ AB-rated generic to Valeant’s Acanya (clindamycin phosphate/ benzoyl peroxide) topical gel, for the treatment of acne vulgaris in patients 12 years and older.More..
Factive® (gemifloxacin) — First-Time Generic

June 15, 2015 — The FDA approved Orchid Healthcare’s AB-rated generic version of LG Life Sciences’ Factive (gemifloxacin) tablets.More..
Intermezzo® (zolpidem) — First-Time Generic

June 3, 2015 — The FDA announced the approval of Novel Labs’ AB-rated generic to Purdue’s Intermezzo (zolpidem) sublingual tablets, for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.More..
Zyvox® (linezolid) Oral Suspension — First-Time Generic

June 3, 2015 — The FDA announced the approval of Roxane’s AB-rated generic to Pfizer’s Zyvox (linezolid) oral suspension.More..
Actonel® (risedronate sodium) — First-Time Generic

June 1, 2015 — Teva and Actavis launched their AB-rated generic versions of Actavis’ Actonel (risedronate sodium) tablets.More..
Atelvia® (risedronate sodium) — First-Time Generic

May 18, 2015 — Teva announced the launch of its AB-rated generic to Actavis’ Atelvia (risedronate sodium) 35 mg delayed-release tablets, for the treatment of osteoporosis in postmenopausal women.More..
Lotronex® (alosetron) — First-Time Generic

May 4, 2015 — The FDA approved Roxane’s AB-rated generic version of Prometheus Laboratories’ Lotronex (alosetron) 0.5 mg and 1 mg tablets.More..
Abilify® (aripiprazole) — First-Time Generic

April 28, 2015 — The FDA approved the first generic versions of Otsuka’s Abilify (aripiprazole). Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals, and Torrent Pharmaceuticals received FDA approval to market generic aripiprazole in multiple strengths and dosage forms.More..
Abilify Discmelt® (aripiprazole) — First-Time Generic

April 28, 2015 — The FDA approved Alembic’s AB-rated generic version of Otsuka’s Abilify Discmelt (aripiprazole) orally disintegrating tablets, for the treatment of schizophrenia and for acute treatment of manic and mixed episodes associated with bipolar I disorder.More..
Carac® (fluorouracil) — First-Time Generic

April 20, 2015 — The FDA approved Spear’s AB-rated generic version of Valeant’s Carac (fluorouracil) 0.5% cream, for topical treatment of multiple actinic or solar keratoses of the face and anterior scalp.More..
Staxyn® (vardenafil) — First-Time Generic

April 22, 2015 — The FDA approved Watson’s AB-rated generic version of Bayer’s Staxyn (vardenafil) orally disintegrating tablets, for the treatment of erectile dysfunction.More..
Copaxone® (glatiramer) — First-Time Generic

April 16, 2015 — Momenta announced the FDA approval of its AP-rated generic version of Teva’s Copaxone (glatiramer) injection, for the treatment of patients with relapsing forms of multiple sclerosis.More..
Kenalog® (triamcinolone acetonide) — First-Time Generic

April 13, 2015 — The FDA approved Perrigo’s AT-rated generic version of Sun Pharma’s Kenalog (triamcinolone acetonide) topical spray, for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.More..
Revatio® (sildenafil citrate) Injection — First-Time Generic

April 1, 2015 — The FDA approved Aurobindo’s AP-rated generic version of Pfizer’s Revatio (sildenafil citrate) injection, for the continued treatment of patients with pulmonary arterial hypertension who are currently prescribed oral Revatio and who are temporarily unable to take oral medication.More..
Generess® Fe (norethindrone/ethinyl estradiol and ferrous fumarate) — First-Time Generic

April 1, 2015 — Mylan launched its AB-rated generic version of Warner Chilcott’s Generess Fe [norethindrone/ethinyl estradiol (EE) and ferrous fumarate] chewable tablets, indicated for use by women to prevent pregnancy.More..
Tasmar® (tolcapone) — First-Time Generic

March 26, 2015 — The FDA approved Par’s AB-rated generic version of Valeant’s Tasmar (tolcapone) tablets, indicated as an adjunct to levodopa and carbidopa for the treatment of signs and symptoms of idiopathic Parkinson’s disease.More..
Methylin® (methylphenidate) — First-Time Generic

February 25, 2015 — The FDA approved Novel Labs’ AB-rated generic version of Shionogi’s Methylin (methylphenidate) chewable tablets, for use in attention deficit disorders and narcolepsy.More..
Glyset® (miglitol) — First-Time Generic

February 24, 2015 — The FDA approved Orient Pharma’s AA-rated generic version of Pfizer’s Glyset (miglitol) tablets, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.More..
Transderm Scop® (scopolamine) — First-Time Generic

January 30, 2015 — The FDA approved Perrigo’s AB-rated generic version of Novartis’ Transderm Scop (scopolamine) transdermal system patch.More..
Lumigan® (bimatoprost) — First-Time Generic

February 23, 2015 — Lupin announced the FDA approval of its AT-rated generic to Allergan’s Lumigan (bimatoprost) 0.03% ophthalmic solution, for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.More..
Mirapex ER™ (pramipexole) — First-Time Generic

February 6, 2015 — Par Pharmaceuticals’ received FDA approval for AB-rated generic versions of Boehringer Ingelheim’s Mirapex ER (pramipexole) 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg and 4.5 mg extended-release (ER) tablets.More..
Namenda® (memantine) — First-Time Generic

January 30, 2015 — The FDA approved Mylan’s AB-rated generic version of Actavis’ Namenda (memantine) tablets, for the treatment of moderate to severe dementia of the Alzheimer’s type.More..
Nexium® (esomeprazole) — First-time Generic

January 26, 2015 — The FDA announced the first-time generic approval of AstraZeneca’s Nexium (esomeprazole) delayed-release (DR) capsules.More..
Norvir® (ritonavir) — First-Time Generic

January 15, 2015 — The FDA approved Roxane’s AB-rated generic version of AbbVie’s Norvir (ritonavir) tablets, for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.More..
Colcrys® (colchicine) — First-Time Generic

January 12, 2015 — Prasco announced the launch of an authorized generic version of Takeda’s Colcrys (colchicine) 0.6 mg tablets.More..
Zyvox® (linezolid) — First-Time Generic

January 5, 2015 — Teva announced the launch of its AP-rated generic to Pfizer’s Zyvox (linezolid) injection. More..

RxNews® is provided solely for educational purposes and is not intended for any other use or purpose.