Is there a recall on bupropion?

Is there a recall on bupropion?

InvaGen Pharmaceuticals Inc. is recalling several lots of bupropion hydrochloride extended-release tablets, USP (SR), because tested samples failed to meet dissolution specifications, according to the April 11, 2018, US Food and Drug Administration (FDA) Enforcement Report.

Has Wellbutrin XL been discontinued?

In October, the U.S. Food and Drug Administration recommended that generic Wellbutrin, or bupropion, made by Impax Laboratories and distributed by Teva Pharmaceuticals, be taken off the market, and Impax and Teva have agreed to stop shipping the drug.

Why was bupropion taken off the market?

In the announcement, the FDA said it had changed the therapeutic equivalence rating for Budeprion XL 300 mg in the agency’s “Approved Drug Products With Therapeutic Equivalence Evaluations” from AB to BX, signifying that Budeprion XL 300 mg fails to demonstrate therapeutic equivalence to the branded product Wellbutrin …

Is generic bupropion as good as Wellbutrin?

The U.S. Food and Drug Administration (FDA) finally has admitted that the generic of the popular antidepressant Wellbutrin XL is not as effective as GlaxoSmithKline’s original drug.

Is bupropion safe to take?

To date, there are no known problems associated with long term use of bupropion. It is a safe and effective medication when used as directed.

What is a good substitute for bupropion?

Atypical antidepressants approved by the FDA

  • Bupropion (Wellbutrin SR, Wellbutrin XL, others)
  • Mirtazapine (Remeron)
  • Nefazodone.
  • Trazodone.
  • Vilazodone (Viibryd)
  • Vortioxetine (Trintellix)

Is bupropion XL the same as Wellbutrin XL?

The generic for Wellbutrin SR is bupropion SR, and the generic for Wellbutrin XL is bupropion XL. All of these products need a prescription, and the prescription must note which version you need.

Is bupropion safe for long term use?

Are There Any Risks For Taking Bupropion For Long Periods Of Time? To date, there are no known problems associated with long term use of bupropion. It is a safe and effective medication when used as directed.

What is a natural alternative to Wellbutrin?

Alternatives to bupropion for depression include:

  • Exercising.
  • Test for food allergies and adjust the diet accordingly.
  • Bright Light Therapy.
  • Eating a nutrient-dense, clean, diet.
  • Vitamin & nutritional supplement therapy, vitamin D, B vitamins, prebiotics, probiotics, etc.
  • Acupuncture, Qigong, traditional Chinese therapies.

Is there a recall on Wellbutrin XL generic?

Generic Wellbutrin XL Recalled, Not As Effective As Original: FDA. Wellbutrin (bupropion) is a popular antidepressant manufactured by GlaxoSmithKline, which was first approved by the FDA in December 1985. The drug was recalled from the market the following year due to a high number of seizures associated with Wellbutrin side effects,…

Are there any generics of bupropion 300 mg?

Data submitted by Actavis, Inc., Mylan Inc., and Par Pharmaceutical confirmed that their generic bupropion HCl ER 300 mg tablet products are therapeutically equivalent to the reference-listed drug, Wellbutrin XL 300 mg. Patients can have confidence that these generics will have the same clinical effect and safety as the brand name drug.

Is the bupropion ER 300 mg equivalent to Wellbutrin XL?

Based on data submitted by Watson, FDA has determined that that company’s generic bupropion HCl ER 300 mg tablet product is not therapeutically equivalent to Wellbutrin XL 300 mg. Watson has agreed to voluntarily withdraw this product from the distribution chain.

Why did the FDA take action on Budeprion XL 300 mg?

FDA’s actions with respect to Budeprion XL 300 mg reflect FDA’s ongoing role in monitoring drugs on the market to ensure their continued safety and efficacy. The role of patients and health care professionals in sharing their experiences with generic versions of Wellbutrin XL 300 mg contributed to further studies, which led to this action.