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Category Archives: GENERIC DRUG
DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Generic approval FDA- Travatan ZTravoprost Ophthalmic Solution/Drops 0.004% – Par Pharmaceutical, Inc.
Travoprost is a synthetic prostaglandin F analogue.
Its chemical name is [1R-[lα(Z),2β(lE,3R*),3α,5α]]-7-[3,5-Dihydroxy-2-[3-hydroxy-4-[3-(trifluoromethyl)phenoxy]-1 -butenyl]cyclopentyl]-5-heptenoic acid, 1 -methylethylester.
It has a molecular formula of C26H35F3O6 and a molecular weight of 500.55.
The chemical structure of travoprost is:
Travoprost is a clear, colorless to slightly yellow oil that is very soluble in acetonitrile, methanol, octanol, and chloroform. It is practically insoluble in water.
TRAVATAN® (travoprost ophthalmic solution) 0.004% is supplied as sterile, buffered aqueous solution of travoprost with a pH of approximately 6.0 and an osmolality of approximately 290 mOsmol/kg.
TRAVATAN® contains Active: travoprost 0.04 mg/mL; Preservative: benzalkonium chloride 0.15 mg/mL; Inactives: polyoxyl 40 hydrogenated castor oil, tromethamine, boric acid, mannitol, edetate disodium, sodium hydroxide and/or hydrochloric acid (to adjust pH) and purified water.
GENERIC APPROVAL MARCH 2013
- Travoprost Ophthalmic Solution/Drops 0.004%
Approved: March 1, 2013 – Par Pharmaceutical, Inc.
Generic for: Travatan Z
Travoprost ophthalmic solution is a topical medication used for controlling the progression of glaucoma or ocular hypertension, by reducing intraocular pressure. It is a synthetic prostaglandin analog (or more specifically, an analog of prostaglandin F2α)[1][2] that works by increasing the outflow of aqueous fluid from the eyes.[3] It is also known by the brand names of Travatan and Travatan Z, manufactured by Alcon, and Travo-Z, manufactured by Micro Labs.
- Alcon Laboratories, Inc. (September 2011). “TRAVATAN – travoprost solution”. DailyMed. Bethesda, MD: U.S. National Library of Medicine. Retrieved 2011-09-30.
- Alcon Laboratories, Inc. (September 2011). “TRAVATAN Z (travoprost) solution”. DailyMed. Bethesda, MD: U.S. National Library of Medicine. Retrieved 2011-09-30.
- AHFS Consumer Medication Information (2011-01-01).“Travoprost Ophthalmic”. MedlinePlus. Bethesda, MD: U.S. National Library of Medicine. Retrieved 2011-09-30.
FDA Approves Generic Suboxone, Buprenorphine HCl and Naloxone HCl Dihydrate SL Tablets
SUBOXONE (buprenorphine and naloxone) sublingual film is an orange film, imprinted with a logo identifying the product and strength in white ink. It contains buprenorphine HCl, a mu-opioid receptor partial agonist and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid receptor antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual administration and is available in four dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone, 4 mg buprenorphine with 1 mg naloxone, 8 mg buprenorphine with 2 mg naloxone, and 12 mg buprenorphine with 3 mg naloxone . Each sublingual film also contains polyethylene oxide, hydroxypropyl methylcellulose, maltitol, acesulfame potassium, lime flavor, citric acid, sodium citrate, FD&C yellow #6, and white ink.
Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure:
 |
Buprenorphine HCl has the molecular formula C29H41NO4 • HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane.
Chemically, naloxone HCl dihydrate is 17-Allyl-4,5 α -epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure:
 |
Naloxone hydrochloride dihydrate has the molecular formula C19H21NO4 • HCl • 2H 20 and the molecular weight is 399.87. It is a white to slightly off-white powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether.
Feb. 25, 2013 — The United States Food and Drug Administration (FDA) has approved generic versions of Reckitt Benckiser Healthcare’s Suboxone sublingual tablets. Buprenorphine HCl and Naloxone HCl Dihydrate SL Tablets, 2 mg/0.5 mg and 8 mg/2 mg will be produced by two U.S. based generic manufacturers – Actavis, Inc. and Amneal Pharmaceuticals, LLC.
Suboxone is indicated for maintenance treatment of opioid dependence.
For the 12 months ending December 31, 2012, Suboxone® tablets had total U.S. sales of approximately $625 million, according to IMS Health data. The generic equivalents are expected to save millions in healthcare costs.
buprenorphine
Chemical Name: (2S)-2-[(-)-(5R,6R,7R,14S)-9α-cyclopropylmethyl-4,5-epoxy-6,14-ethano-3-hydroxy-6-methoxymorphinan-7-yl]-3,3-dimethylbutan-2-ol
Uses: Pain, Opiate/Opioid Abuse Treatment
Routes: Sublingual
Half-Life (H½): 37 Hours
Bioavailability: ~50-60% (Sublingual Tablet)
Protein Binding: 96%
Potency: 30-50x (Oral Morphine)
Mafenide Acetate Topical Solution 5% Approved: February 12, 2013 – Par Pharmaceutical, Inc. Sulfamylon
Mafenide acetate, USP is a synthetic antimicrobial agent designated chemically as a-amino-p- toluenesulfonamide monoacetate. It has the following structural formula:
 |
C7H10N2O2S • C2H4O2
M.W. 246.29Mafenide acetate, USP is a white, crystalline powder which is freely soluble in water.
SULFAMYLON® (mafenide acetate) For 5% Topical Solution is provided in packets containing 50 g of sterile mafenide acetate to be reconstituted in 1000 mL of Sterile Water for irrigation, USP or 0.9% Sodium Chloride Irrigation, USP. After mixing, the solution contains 5% w/v of mafenide acetate. The solution is an antimicrobial preparation suitable for topical administration. The solution Is not for Injection. The reconstituted solution may be held up to 28 days after preparation if stored in unopened containers. ONCE A CONTAINER IS OPENED, ANY UNUSED PORTION SHOULD BE DISCARDED AFTER 48 HOURS. Store the reconstituted solution at 20° to 25°C (68° to 77°F). Limited storage periods at 15° to 30°C (59° to 86°F) are acceptable.
- Mafenide Acetate Topical Solution 5%
Approved: February 12, 2013 – Par Pharmaceutical, Inc.
Generic for: Sulfamylon
Teva Announces FDA Approval of Generic Adderall XR®
FEB 14 2013, Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for the generic version of Shire’s Adderall XR®Capsules, 5mg, 10mg, 15mg, 20mg, 25mg and 30 mg capsules for the treatment of attention deficit hyperactivity disorder. Adderall XR® had annual sales, including brand and generic sales, of approximately $2 billion in the United States, based on IMS sales data as of December 31, 2012.
Teva currently sells a generic version of Adderall XR® Capsules under a 2006 license and distribution agreement with Shire as part of a settlement of patent litigation between Shire and Teva’s subsidiary Barr Pharmaceuticals. Under the terms of the agreement, Teva has the right to be supplied product by Shire through April 1, 2014.
Adderall is a psychostimulant medication that contains amphetamine. It is used for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy.[1] Adderall is a combination of four amphetamine salts (racemic amphetamine aspartate monohydrate, racemic amphetamine sulfate, dextroamphetamine saccharide, and dextroamphetamine sulfate). It is a dopamine releasing agent, a norepinephrine releasing agent, and can be mildly serotonergic.[2] It is available in two formulations: IR (Instant Release) and XR (Extended Release). The immediate release formulation is indicated for use in attention deficit hyperactivity disorder (ADHD) and narcolepsy,[3] while the XR formulation is approved for use only with attention deficit hyperactivity disorder (ADHD).[2]
Important side effects of therapeutic dextroamphetamine include stunted growth in young people and occasionally a psychosis can occur at therapeutic doses during chronic therapy as a treatment emergent side effect.[4] When abused at high doses, the risk of experiencing side effects and the severity of side effects increases. Side effects may include sweating or shaking.
Like other stimulant drugs, such as methamphetamine and cocaine, Adderall directly affects the mesolimbic reward pathway in the brain. Amphetamine salt preparations are considered to have high abuse potential, and it is classified as Schedule II by the US DEA. With the Safe Streets and Communities Act in Canada, Adderall has been reclassified from Schedule III to Schedule I.[5]
- “Adderall”. The American Society of Health-System Pharmacists. http://www.drugs.com/monograph/adderall.html. Retrieved 3 April 2
- “Adderall XR prescribing information”. Shire US. March 2009. http://pi.shirecontent.com/PI/PDFs/AdderallXR_USA_ENG.PDF. Retrieved 2009-06-23.
- “ADDERALL (CII)” (PDF). Food and Drug Administration. February 2007. http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011522s040lbl.pdf. Retrieved 2009-06-23.
- Berman, SM.; Kuczenski, R.; McCracken, JT.; London, ED. (Feb 2009). “Potential adverse effects of amphetamine treatment on brain and behavior: a review.”. Mol Psychiatry 14 (2): 123–42. doi:10.1038/mp.2008.90. PMID 18698321.
- C-10
| Combination of | |
|---|---|
| Dextroamphetamine | Psychostimulant |
| Amphetamine | Psychostimulant |
| Clinical data | |
| Trade names | Adderall, Adderall XR |
| AHFS/Drugs.com | monograph |
| MedlinePlus | a601234 |
| Licence data | US Daily Med:link |
| Pregnancy cat. | C (US) |
| Legal status | Schedule I (CA) Schedule II (US) |
| Dependence liability | High |
| Routes | (Medical) Oral, (Recreational) Oral, Insufflated, Intravenous |
| Identifiers | |
| CAS number | 51-64-9 300-62-9 |
Sandoz launches first generic version of Cleocin Phosphate® in Dextrose 5%
Clindamycin rINN (pron.: /klɪndəˈmaɪsɨn/) is a lincosamide antibiotic. It is usually used to treat infections with anaerobic bacteria, but can also be used to treat some protozoal diseases, such as malaria. It is a common topical treatment for acne and can be useful against some methicillin-resistant Staphylococcus aureus (MRSA) infections.[1]
The most severe common adverse effect of clindamycin is Clostridium difficile-associated diarrhea (the most frequent cause of pseudomembranous colitis). Although this side effect occurs with almost all antibiotics, including beta-lactam antibiotics, it is classically linked to clindamycin use.[2]
Clindamycin is marketed under various trade names, including Dalacin, Lincocin (Bangladesh), and Daclin. Combination products include Duac, BenzaClin, Clindoxyl and Acanya (in combination with benzoyl peroxide), and Ziana (with tretinoin). Clindamycin is also available as a generic drug.
Clindamycin is a semisynthetic derivative of lincomycin, a natural antibiotic produced by the actinobacterium Streptomyces lincolnensis. It is obtained by 7(S)-chloro–substitution of the 7(R)-hydroxyl group of lincomycin.[34][35] The synthesis of clindamycin was first announced by BJ Magerlein, RD Birkenmeyer, and F Kagan on the fifth Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in 1966.[36] It has been on the market since 1968.
- Daum RS (2007). “Clinical practice. Skin and soft-tissue infections caused by methicillin-resistant Staphylococcus aureus”. N Engl J Med 357 (4): 380–90. doi:10.1056/NEJMcp070747. PMID 17652653.
- Thomas C, Stevenson M, Riley TV (2003). “Antibiotics and hospital-acquired Clostridium difficile-associated diarrhoea: a systematic review”. J Antimicrob Chemother 51 (6): 1339–50. doi:10.1093/jac/dkg254. PMID 12746372. http://jac.oxfordjournals.org/content/51/6/1339.full.pdf.
- Brook I, Lewis MA, Sándor GK, Jeffcoat M, Samaranayake LP, Vera Rojas J. Clindamycin in dentistry: more than just effective prophylaxis for endocarditis? Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 ;100:550-8
- “Cleocin I.V. Indications & Dosage”. RxList.com. 2007. http://www.rxlist.com/cgi/generic/clindamyciniv_ids.htm. Retrieved 2007-12-01.
- Darley ES, MacGowan AP (2004). “Antibiotic treatment of gram-positive bone and joint infections”. J Antimicrob Chemother 53 (6): 928–35. doi:10.1093/jac/dkh191. PMID 15117932. http://jac.oxfordjournals.org/content/53/6/928.full.pdf.
- Feldman S, Careccia RE, Barham KL, Hancox J (May 2004). “Diagnosis and treatment of acne”. Am Fam Physician 69 (9): 2123–30. PMID 15152959. http://www.aafp.org/afp/2004/0501/p2123.pdf.
Sun Pharma Global FZE, First Generic Version of Cancer Drug Doxil (doxorubicin hydrochloride liposome injection) Approved
Sun Pharma Global FZE drug, approved by USFDA
DOXIL (doxorubicin HCl liposome injection) is doxorubicin hydrochloride (HCl) encapsulated in STEALTH® liposomes for intravenous administration.
Doxorubicin is an anthracycline topoisomerase inhibitor isolated from Streptomyces peucetius var. caesius.
Doxorubicin HCl, which is the established name for (8S,10S)-10-[(3-amino-2,3,6-trideoxyα- L-lyxo-hexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy5,12- naphthacenedione hydrochloride, has the following structure:
 |
The molecular formula of the drug is C27H29NO11•HCl; its molecular weight is 579.99.
DOXIL (doxorubicin hcl liposome injection) is provided as a sterile, translucent, red liposomal dispersion in 10-mL or 30-Ml glass, single use vials. Each vial contains 20 mg or 50 mg doxorubicin HCl at a concentration of 2 mg/mL and a pH of 6.5. The STEALTH® liposome carriers are composed of N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero3- phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and cholesterol, 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 2 mg; histidine as a buffer; hydrochloric acid and/or sodium hydroxide for pH control; and sucrose to maintain isotonicity. Greater than 90% of the drug is encapsulated in the STEALTH® liposomes
MONDAY Feb. 4, 2013 — The first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection) has been approved by the U.S. Food and Drug Administration, which says the action should help relieve shortages of the brand-name medication.
Doxil is on the agency’s drug shortage list. The list empowers the FDA’s Office of Generic Drugs to grant priority review to generic equivalents, the agency said Monday in a news release.
Noting that generics were of the same quality and strength as the original drugs, the FDA said: “Generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.”
Generic Doxil will be produced by Sun Pharma Global FZE in 20 milligram and 50 milligram vials.
New Drug Approvals