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 Number | Generic Name | ANDA Applicant | Brand Name | ANDA Approval Date | ANDA Indication+ | |
|---|---|---|---|---|---|---|
| 20 | 210334 | Phenylephrine Hydrochloride Injection USP, 10 mg/mL SingleDose Via | Cipla Limited | Phenylephrine Hydrochloride | 4/27/2018 | Indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia |
| 19 | 210333 | Phenylephrine Hydrochloride Injection USP, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package | Cipla Limited | Vazculep (Phenylephrine Hydrochloride) Injection USP, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package | 4/27/2018 | For the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesi |
| 18 | 202159 | Hydromorphone Hydrochloride Injection USP, 2 mg/mL Single-Dose Vial | Eurohealth International Sarl | Dilaudid (Hydromorphone Hydrochloride) Injection USP, 2 mg/mL Single-Dose Vial | 4/27/2018 | For management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate |
| 17 | 208342 | Miglustat Capsules, 100 mg | Amerigen Pharmaceuticals Limited | Zavesca (Miglustat) Capsules, 100 mg | 4/17/2018 | A 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 | 210088 | Loratadine Chewable Tablets USP, 5 mg (OTC) | Sun Pharma Global FZE | Children’s Claritin (Loratadine) Chewable Tablets, 5 mg | 4/16/2018 | For seasonal allergic rhinitis and idiopathic urticaria |
| 15 | 208790 | Ertapenem for Injection, 1 gram (base)/ Single-dose vial | ACS DOBFAR SPA | Invanz (Ertapenem) for Injection, 1 gram (base)/ Single-dose vial | 4/16/2018 | 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:
|
| 14 | 206133 | Everolimus Tablets, 0.25 mg, 0.5 mg, and 0.75 mg | West-Ward Pharmaceuticals International Limited | Zortress (Everolimus) Tablets, 0.25 mg, 0.5 mg, and 0.75 m | 4/12/2018 | For 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 | 090308 | Clozapine Orally Disintegrating Tablets, 12.5 mg | Barr Laboratories Inc. | Fazaclo (Clozapine) Orally Disintegrating Tablets, 12.5 mg | 4/9/2018 | For use as an anti-psychotic |
| 12 | 204636 | Ropivacaine Hydrochloride Injection USP, 0.2%, 200 mg/100 mL and 400 mg/200 mL (2 mg/mL), single-dose infusion bottles | Akorn Inc. | Naropin (Ropivacaine Hydrochloride Injection USP), 0.2%, 200 mg/100 mL and 400 mg/200 mL (2 mg/mL), single-dose infusion bottles | 3/16/2018 | Indicated for local, regional anesthesia and acute pain management |
| 11 | 208915 | Cinacalcet Hydrochloride Tablets, 30 mg (base), 60 mg (base), and 90 mg (base) | Cipla Limited | Sensipar 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 Limited | Sensipar 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 |
| 9 | 209594 | Baclofen Injection, 20,000 mcg/20 mL (1,000 mcg/mL) Single-dose Vials | Mylan Laboratories Limited | Gablofen (Baclofen) Injection, 20,000 mcg/20 mL (1,000 mcg/mL) Single-dose Vials | 3/6/2018 | For use in the management of severe spasticity of cerebral or spinal origin in adult and pediatric patients age 4 years and above |
| 8 | 208234 | Desflurane USP, Liquid for Inhalation | Shanghai Hengrui Pharmaceutical Co., Ltd. | Suprane (Desflurane USP), Liquid for Inhalation | 2/26/2018 | Indicated for general anesthesia |
| 7 | 207457 | Sumatriptan 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 |
| 6 | 207567 | Trientine Hydrochloride Capsules USP, 250 mg | Watson Laboratories, Inc | Syprine (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 |
| 5 | 091612 | Tenofovir Disoproxil Fumarate Tablets, 150 mg, 200 mg, 250 mg | Teva Pharmaceuticals USA, Inc. | Viread (Tenofovir Disoproxil Fumarate) Tablets, 150 mg, 200 mg, and 250 mg | 1/26/2018 | For the treatment of HIV-1 infection; for the treatment of chronic hepatitis B |
| 4 | 090647 | Tenofovir Disoproxil Fumarate Tablets, 150 mg, 200 mg, 250 mg | Aurobindo Pharma Limited | Viread (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 |
| 3 | 210375 | Levocetirizine Dihydrochloride Tablets USP, 5 mg | Dr. Reddy’s Laboratories Limited | Xyzal (Levocetirizine Dihydrochloride Tablets USP, 5 mg) Allergy 24HR | 1/19/2018 | For 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 |
| 2 | 206223 | Remifentanil Hydrochloride for Injection, 1 mg/vial, 2 mg/vial, and 5 mg/vial | Fresenius Kabi USA, LLC | Ultiva® Injection, 1 mg/vial, 2 mg/vial, and 5 mg/vial | 1/16/2018 | For 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 |
| 1 | 209688 | Potassium Chloride Extended-Release Tablets USP, 10 MEQ (750 mg), 20 MEQ (1500 mg) | Paddock LLC | K-Tab (Potassium Chloride Extended-Release Tablets) USP, 10 MEQ (750 mg), 20 MEQ (1500 mg) | 1/12/2018 | For 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.