Is phenylpropanolamine banned by the FDA?

FDA is taking steps to remove phenylpropanolamine from all drug products and has requested that all drug companies discontinue marketing products containing phenylpropanolamine.

Is phenylpropanolamine over the counter?

Phenylpropanolamine is a drug used to relieve nasal congestion due to colds , hay fever , upper respiratory allergies, and sinusitis . It is available in nonprescription products alone and in combination with other nonprescription drugs, to treat symptoms of allergy , colds, and upper respiratory infections.

Is PPA banned?

In the United States, PPA is no longer sold due to an increased risk of haemorrhagic stroke.

How can I get FDA license in the Philippines?

How to Get a License to Operate from the FDA in the Philippines

1. Petition form.
2. Joint Affidavit of Undertaking.
3. Certificate of Attendance to an FDA-sponsored seminar on licensing of establishments.
4. Proof of business registration.
5. Proof of occupancy or business address.
6. Floor plan and vicinity map.

Is the FDA taking steps to remove phenylpropanolamine?

The Food and Drug Administration (FDA) is taking steps to remove phenylpropanolamine (PPA) from all drug products and has requested that all drug companies discontinue marketing products containing PPA. In addition, FDA has issued a public health advisory concerning phenylpropanolamine.

Is there a public health advisory for phenylpropanolamine?

In addition, FDA has issued a public health advisory concerning phenylpropanolamine. This drug is an ingredient that was used in many over-the-counter (OTC) and prescription cough and cold medications as a decongestant and in OTC weight loss products.

When was phenylpropanolamine marketed as an OTC drug?

Phenylpropanolamine has been marketed for many years. During the early 1970’s, FDA initiated a scientific review of OTC drug products to determine the safety and effectiveness of products marketed in the United States. That review included phenylpropanolamine.

Is there a risk of stroke from phenylpropanolamine hydrochloride?

This summary is to provide additional information to health care professionals in conjunction with the Food and Drug Administration (FDA) public health advisory concerning the risk of hemorrhagic stroke associated with phenylpropanolamine hydrochloride.