Regulatory Open Forum

Can anyone explain to me what happens to approved generic drugs when the branded drug switches from Rx to OTC.  If it's a full switch, what happens to the Rx generics as the result?

Thanks so much,

Marcy

------------------------------
Marcy Sussman RAC
Potomac MD
United States
------------------------------

Probably withdraw from the market I.e. no more ANDAs as Rx.

------------------------------
GRSAOnline
------------------------------

Original Message:
Sent: 15-Oct-2018 08:20
From: Marcy Sussman
Subject: Switch

Can anyone explain to me what happens to approved generic drugs when the branded drug switches from Rx to OTC.  If it's a full switch, what happens to the Rx generics as the result?

Thanks so much,

Marcy

------------------------------
Marcy Sussman RAC
Potomac MD
United States
------------------------------

I guess I assumed that they would have an opportunity to submit an ANDA to switch after a certain period of time, but during that "waiting" time, what happens.  Are there generics still sold Rx?  I didn't think you could have the same drug, at same dose and same indication on the market at the same time...

------------------------------
Marcy Sussman RAC
Potomac MD
United States
------------------------------

Original Message:
Sent: 15-Oct-2018 17:49
From: Narayan Rao
Subject: Switch

Probably withdraw from the market I.e. no more ANDAs as Rx.

------------------------------
GRSAOnline

Original Message:
Sent: 15-Oct-2018 08:20
From: Marcy Sussman
Subject: Switch

Can anyone explain to me what happens to approved generic drugs when the branded drug switches from Rx to OTC.  If it's a full switch, what happens to the Rx generics as the result?

Thanks so much,

Marcy

------------------------------
Marcy Sussman RAC
Potomac MD
United States
------------------------------

As far as your ANDA is approved as Rx and in the commercial market, there is nothing to do until you are notified by FDA.

If OTC has been switched to NDA then Mr. Rao is absolutely right that OTC manufacturers will be notified by FDA to withdraw their products from the commercial market, because NDA holder has shown the safety study for that product.

In this case Rx switched to OTC which shows no any safety concern for that product, so approved generic has no effect. Only concern can come as part of the labeling change and that happen only upon FDA recommendation.

------------------------------
Gaurang Bhavsar, MS, RAC
Manager, R&D and RA
Sunrise Pharmaceutical, Inc.
Rahway, NJ 07065
USA
------------------------------

Original Message:
Sent: 16-Oct-2018 07:28
From: Marcy Sussman
Subject: Switch

I guess I assumed that they would have an opportunity to submit an ANDA to switch after a certain period of time, but during that "waiting" time, what happens.  Are there generics still sold Rx?  I didn't think you could have the same drug, at same dose and same indication on the market at the same time...

------------------------------
Marcy Sussman RAC
Potomac MD
United States

Original Message:
Sent: 15-Oct-2018 17:49
From: Narayan Rao
Subject: Switch

Probably withdraw from the market I.e. no more ANDAs as Rx.

------------------------------
GRSAOnline

Original Message:
Sent: 15-Oct-2018 08:20
From: Marcy Sussman
Subject: Switch

Can anyone explain to me what happens to approved generic drugs when the branded drug switches from Rx to OTC.  If it's a full switch, what happens to the Rx generics as the result?

Thanks so much,

Marcy

------------------------------
Marcy Sussman RAC
Potomac MD
United States
------------------------------

Hi Marcy,

Below is an example of a recent FDA decision for an NDA product that was switched to an OTC by the innovator and therefore the associated approved ANDAs with Rx label are now considered misbranded unless they switch to the OTC versions:

Product Miralax by Bayer:

FDA has long interpreted the provisions to mean that section 503(b) of the FD&C Act does not permit the same active ingredient to be simultaneously marketed in both a prescription drug product and a nonprescription drug product, unless a meaningful difference exists between the two that makes the prescription product safe only under the supervision of a licensed practitioner."

Since FDA concluded that all of the indications the MiraLAX product met the criteria for OTC and that all of the indications were now considered to be OTC, the FDA termed this a "complete switch" rather than a partial switch, which would have had some leave behind Rx indications. In April 2007, FDA sent letters to the holders of the approved generic versions of MiraLAX explaining their position and letting them know that their products marketed with the Rx symbol would be considered misbranded, but let them know that they could submit new ANDAs for the OTC product.

As such, and with the denial of the hearing, FDA is withdrawing the approval of any of the previously approved or discontinued ANDA for the Rx versions of this product.

Hope this clarifies my previous post!

------------------------------
GRSAOnline
------------------------------

Original Message:
Sent: 15-Oct-2018 17:49
From: Narayan Rao
Subject: Switch

Probably withdraw from the market I.e. no more ANDAs as Rx.

------------------------------
GRSAOnline

Original Message:
Sent: 15-Oct-2018 08:20
From: Marcy Sussman
Subject: Switch

Can anyone explain to me what happens to approved generic drugs when the branded drug switches from Rx to OTC.  If it's a full switch, what happens to the Rx generics as the result?

Thanks so much,

Marcy

------------------------------
Marcy Sussman RAC
Potomac MD
United States
------------------------------

Thanks so much.

------------------------------
Marcy Sussman RAC
Potomac MD
United States
------------------------------

Original Message:
Sent: 16-Oct-2018 12:13
From: Narayan Rao
Subject: Switch

Hi Marcy,

Below is an example of a recent FDA decision for an NDA product that was switched to an OTC by the innovator and therefore the associated approved ANDAs with Rx label are now considered misbranded unless they switch to the OTC versions:

Product Miralax by Bayer:

FDA has long interpreted the provisions to mean that section 503(b) of the FD&C Act does not permit the same active ingredient to be simultaneously marketed in both a prescription drug product and a nonprescription drug product, unless a meaningful difference exists between the two that makes the prescription product safe only under the supervision of a licensed practitioner."

Since FDA concluded that all of the indications the MiraLAX product met the criteria for OTC and that all of the indications were now considered to be OTC, the FDA termed this a "complete switch" rather than a partial switch, which would have had some leave behind Rx indications. In April 2007, FDA sent letters to the holders of the approved generic versions of MiraLAX explaining their position and letting them know that their products marketed with the Rx symbol would be considered misbranded, but let them know that they could submit new ANDAs for the OTC product.

As such, and with the denial of the hearing, FDA is withdrawing the approval of any of the previously approved or discontinued ANDA for the Rx versions of this product.

Hope this clarifies my previous post!

------------------------------
GRSAOnline

Original Message:
Sent: 15-Oct-2018 17:49
From: Narayan Rao
Subject: Switch

Probably withdraw from the market I.e. no more ANDAs as Rx.

------------------------------
GRSAOnline

Original Message:
Sent: 15-Oct-2018 08:20
From: Marcy Sussman
Subject: Switch

Can anyone explain to me what happens to approved generic drugs when the branded drug switches from Rx to OTC.  If it's a full switch, what happens to the Rx generics as the result?

Thanks so much,

Marcy

------------------------------
Marcy Sussman RAC
Potomac MD
United States
------------------------------