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General Medication Discussion This section is to be used for general medication discussion and other medications not broken out in their own respective forums.

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Old 10-06-17, 03:57 PM
meenmokanik meenmokanik is offline
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Metadate discontinued???

Our local pharmacy here in the U.S. is telling us that they can't get Metadate or its generic anymore. Is anyone else having this issue? We have went through every medication under the sun and this one has been the best one for my son so far.
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Old 10-07-17, 06:35 AM
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Re: Metadate discontinued???

https://www.federalregister.gov/docu...-10-milligrams


found this:


Quote:
Determination That METADATE ER (Methylphenidate Hydrochloride) Extended-Release Tablet, 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

A Notice by the Food and Drug Administration on 07/05/2013

DOCUMENT DETAILS
Printed version:
PDF
Publication Date:
07/05/2013
Agencies:
Food and Drug Administration
Document Type:
Notice
Document Citation:
78 FR 40484
Page:
40484-40485 (2 pages)
Agency/Docket Number:
Docket No. FDA-2013-P-0303
Document Number:
2013-16101
DOCUMENT DETAILS
ENHANCED CONTENT
Regulations.gov Logo
Docket Number:
FDA-2013-P-0303
ENHANCED CONTENT
PUBLISHED DOCUMENT
AGENCY:
Food and Drug Administration, HHS.

ACTION:
Notice.

SUMMARY:
The Food and Drug Administration (FDA) has determined that METADATE ER (methylphenidate hydrochloride (HCl)) extended-release tablet, 10 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for methylphenidate HCl extended-release tablet, 10 mg, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT:
Reena Raman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6238, Silver Spring, MD 20993-0002, 301-796-7577.

SUPPLEMENTARY INFORMATION:
In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products with Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.

METADATE ER (methylphenidate HCl) extended-release tablet, 10 mg, is the subject of ANDA 40-306, held by UCB, Inc., and initially approved on October 20, 1999. METADATE ER is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: Moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.

In a letter dated November 4, 2011, UCB, Inc., notified FDA that METADATE ER (methylphenidate HCl) extended-release tablet, 10 mg, had been discontinued, and FDA moved the drug product to the “Discontinued Drug Product List” section of the Orange Book.

Tedor Pharma Inc. submitted a citizen petition dated March 6, 2013 (Docket No. FDA-2013-P-0303), under 21 CFR 10.30, requesting that the Agency determine whether METADATE ER (methylphenidate HCl) extended-release tablet, 10 mg, was withdrawn from sale for reasons of safety or effectiveness.

After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that METADATE ER (methylphenidate HCl) extended-release tablet, 10 mg, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that METADATE ER (methylphenidate HCl) extended-release tablet, 10 mg, was withdrawn for Start Printed Page 40485reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of this product from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness.

Accordingly, the Agency will continue to list METADATE ER (methylphenidate HCl) extended-release tablet, 10 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to METADATE ER (methylphenidate HCl) extended-release tablet, 10 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
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Old 10-07-17, 02:21 PM
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Re: Metadate discontinued???

It looks like they've discontinued the 10mg dose, but may [?] still be making the 20mg dose form, based on the FDA's drug database. That said, I do not see Metadate listed on UCB (the manufacturer)'s "Products" page.

The note that Sarah posted above means that they dicontinued the medication (at least at one dose) due to a business decision, rather than due to some problem with the medication itself.
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