Drugs

First Generic Drug Approvals

Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for patients.

“First generics” are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States. FDA considers first generics to be important to public health, and prioritizes review of these submissions.

Note: Approved drugs are not always available on or after the listed approval date. Please contact the listed ANDA applicant for more information about a drug product’s availability.

First-Time Generic Drug Approvals 2018*

 ANDA NumberGeneric NameANDA ApplicantBrand NameANDA Approval DateANDA Indication+
29207607Buprenorphine and Naloxone Sublingual Film, 8 mg/2 mg and 12 mg/3 mgMylan Technologies Inc.Suboxone6/14/2018For the treatment of opioid dependence.
28205806Buprenorphine and Naloxone Sublingual Film, 4 mg/1 mg and 12 mg/3 mgDr. Reddy's Laboratories SASuboxone6/14/2018For the treatment of opioid dependence.
27205299Buprenorphine and Naloxone Sublingual Film, 2 mg/0.5 mg and 8 mg/2 mgDr. Reddy's Laboratories SASuboxone6/14/2018For the treatment of opioid dependence.
26207329Oxybutynin Chloride Gel, 10% Par Pharmaceutical, Inc.Gelnique (Oxybutynin Chloride) Gel, 10%5/31/2018A muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
25090141Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg Teva Pharmaceutical USA, Inc.Cialis Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg5/22/2018Indicated for the treatment of:
• Erectile dysfunction (ED)
• The signs and symptoms of benign prostatic hyperplasia (BPH)
• Ed and the signs and symptoms of BPH (ED/BPH)
24206049Methylphenidate Hydrochloride for Extended-Release Oral Suspension, 300 mg/60 mL total volume, 600 mg/120 mL total volume, 750 mg/150 mL total volume, and 900 mg/180 mL total volume (5 mg/mL) Actavis Laboratories FL, Inc.QUILLIVANT XR® (Methylphenidate Hydrochloride) for Extended-Release Oral Suspension, 25 mg per 5 mL5/17/2018A central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)
23091600Colesevelam Hydrochloride Tablets, 625 mg Impax Laboratories, Inc.Welchol (Colesevelam Hydrochloride)Tablets, 625 mg4/27/2018Indicated as an adjunct to diet and exercise to:
• Reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia as monotherapy or in combination with a hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (statin)
• Reduce LDL-C levels in boys and post-menarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia as monotherapy or in combination with a statin after failing an adequate trial of diet therapy
22209373Phytonadione Tablets USP, 5 mg Amneal Pharmaceuticals Company GmbHMephyton (Phytonadione) Tablets, 5 mg5/11/20181. Anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives.
2. Hypoprothrombinemia secondary to antibacterial therapy.
3. Hypoprothrombinemia secondary to administration of salicylates.
4. Hypoprothrombinemia secondary to obstructive jaundice or biliary fistulas but only if bile salts are administered concurrently, since otherwise the oral vitamin K will not be absorbed
21209467Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) Multiple-Dose Vials Zydus Pharmaceuticals (USA), Inc.Quelicin (Succinylcholine Chloride) Injection USP, 200 mg/10 mL (20 mg/mL) Multiple-Dose Vials5/4/2018Indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation
20210334Phenylephrine Hydrochloride Injection USP, 10 mg/mL SingleDose Via Cipla LimitedPhenylephrine Hydrochloride4/27/2018Indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia
19 210333Phenylephrine Hydrochloride Injection USP, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package Cipla LimitedVazculep (Phenylephrine Hydrochloride) Injection USP, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package4/27/2018For the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesi
18 202159Hydromorphone Hydrochloride Injection USP, 2 mg/mL Single-Dose Vial Eurohealth International SarlDilaudid (Hydromorphone Hydrochloride) Injection USP, 2 mg/mL Single-Dose Vial4/27/2018For management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate
17 208342Miglustat Capsules, 100 mg Amerigen Pharmaceuticals LimitedZavesca (Miglustat) Capsules, 100 mg4/17/2018A glucosylceramide synthase inhibitor indicated as monotherapy for treatment of adult patients with mild/moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option
16 210088Loratadine Chewable Tablets USP, 5 mg (OTC) Sun Pharma Global FZEChildren’s Claritin (Loratadine) Chewable Tablets, 5 mg4/16/2018For seasonal allergic rhinitis and idiopathic urticaria
15 208790Ertapenem for Injection, 1 gram (base)/ Single-dose vial ACS DOBFAR SPA Invanz (Ertapenem) for Injection, 1 gram (base)/ Single-dose vial4/16/2018

A penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria:

  • Complicated intra-abdominal infections.
  • Complicated skin and skin structure infections, including diabetic foot   
    infections without osteomyelitis.
  • Community-acquired pneumonia.
  • Complicated urinary tract infections including pyelonephritis. 
  • Acute pelvic infections including postpartum endomyometritis, septic abortion and post surgical gynecologic infections.
    Ertapenem for Injection is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery.
14 206133Everolimus Tablets, 0.25 mg, 0.5 mg, and 0.75 mg West-Ward Pharmaceuticals International LimitedZortress (Everolimus) Tablets, 0.25 mg, 0.5 mg, and 0.75 m4/12/2018For organ rejection prophylaxis in renal transplant patients with low-moderate immunologic risk, in combination with basiliximab induction and reduced doses of cyclosporine and corticosteroids
13 090308Clozapine Orally Disintegrating Tablets, 12.5 mg Barr Laboratories Inc.Fazaclo (Clozapine) Orally Disintegrating Tablets, 12.5 mg4/9/2018For use as an anti-psychotic
12204636Ropivacaine Hydrochloride Injection USP, 0.2%, 200 mg/100 mL and 400 mg/200 mL (2 mg/mL), single-dose infusion bottlesAkorn Inc.Naropin (Ropivacaine Hydrochloride Injection USP), 0.2%, 200 mg/100 mL and 400 mg/200 mL (2 mg/mL), single-dose infusion bottles 3/16/2018Indicated for local, regional anesthesia and acute pain management
11 208915Cinacalcet Hydrochloride Tablets, 30 mg (base), 60 mg (base), and 90 mg (base)Cipla LimitedSensipar Tablets, 30 mg (base), 60 mg (base), and 90 mg (base)3/8/2018 For the treatment of Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis, Hypercalcemia in adult patients with Parathyroid Carcinoma (PC), and severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy
10 206125 Cinacalcet Hydrochloride Tablets, 30 mg (base), 60 mg (base) and 90 mg (base)Aurobindo Pharma LimitedSensipar Tablets, 30 mg (base), 60 mg (base), and 90 mg  3/8/2018 For the treatment of Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis, Hypercalcemia in adult patients with Parathyroid Carcinoma (PC), and severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy
209594Baclofen Injection, 20,000 mcg/20 mL (1,000 mcg/mL) Single-dose VialsMylan Laboratories Limited Gablofen (Baclofen) Injection, 20,000 mcg/20 mL (1,000 mcg/mL) Single-dose Vials3/6/2018 For use in the management of severe spasticity of cerebral or spinal origin in adult and pediatric patients age 4 years and above
 
208234Desflurane USP, Liquid for Inhalation Shanghai Hengrui Pharmaceutical Co., Ltd. Suprane (Desflurane USP), Liquid for Inhalation   2/26/2018 Indicated for general anesthesia
207457Sumatriptan and Naproxen Tablets, 85 mg/500 mg  Aurobindo Pharma Limited Treximet (Sumatriptan and Naproxen) Tablets, 85 mg/500 mg   2/15/2018 Indicated for the acute treatment of migraine with or without aura in adults 
207567Trientine Hydrochloride Capsules USP, 250 mg 
 
Watson Laboratories, IncSyprine (Trientine Hydrochloride) Capsules USP, 250 mg 2/7/2018 Indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Syprine should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects
091612Tenofovir Disoproxil Fumarate Tablets, 150 mg, 200 mg, 250 mgTeva Pharmaceuticals USA, Inc.Viread (Tenofovir Disoproxil Fumarate) Tablets, 150 mg, 200 mg, and 250 mg1/26/2018For the treatment of HIV-1 infection; for the treatment of chronic hepatitis B
090647Tenofovir Disoproxil Fumarate Tablets, 150 mg, 200 mg, 250 mgAurobindo Pharma LimitedViread (Tenofovir Disoproxil Fumarate) Tablets, 150 mg, 200 mg, and 250 mg 1/26/2018 Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older.  Indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older
210375Levocetirizine Dihydrochloride Tablets USP, 5 mgDr. Reddy’s Laboratories LimitedXyzal (Levocetirizine Dihydrochloride Tablets USP, 5 mg) Allergy 24HR1/19/2018For temporary relief of these symptoms due to hay fever or other respiratory allergies: runny nose; itchy, watery eyes; sneezing; itching of the nose or throat
206223Remifentanil Hydrochloride for Injection, 1 mg/vial, 2 mg/vial, and 5 mg/vialFresenius Kabi USA, LLCUltiva® Injection, 1 mg/vial, 2 mg/vial, and 5 mg/vial 1/16/2018For intravenous administration as: an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures; for continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting; as an analgesic component of monitored anesthesia care in adult patients
209688Potassium Chloride Extended-Release Tablets USP, 10 MEQ (750 mg), 20 MEQ (1500 mg)Paddock LLCK-Tab (Potassium Chloride Extended-Release Tablets) USP, 10 MEQ (750 mg), 20 MEQ (1500 mg)1/12/2018For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patientes with hypokalemic periodic paralysis; for the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop (digitalized patients or patients with significant cardiac arrhythmias

Note: As outlined in the Proposed Criteria for First Generic Submissions for Purposes of ANDA, certain ANDAs are deemed “first generic” for the purposes of review prioritization. In this context, a first generic application is any received ANDA: (1) That is a first-to-file ANDA eligible for 180-day exclusivity, or for which there are no blocking patents or exclusivities; and (2) for which there is no previously-approved ANDA for the drug product.

*This table reflects current data as of the date the listed approval was made. Post-approval status changes, including approved use or indications, approval date, approval status, etc. are not reflected here. To view the most current information on any ANDA listed, please check its Drugs@FDA listing.
+Due to space limitations, abbreviated indications are listed. For full indication information, please check Drugs@FDA.

To view all Generic Drug Approvals and Tentative Approvals, use the "Drug Approval Reports by Month" feature on Drugs@FDA and select "Original Abbreviated New Drug Approvals (ANDAs) by Month" for Generic Approvals or "Tentative Approvals by Month" for Tentative Approvals. The database is updated daily.

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Page Last Updated: 06/19/2018
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