Showing posts with label New Generic Drug Approval. Show all posts
Showing posts with label New Generic Drug Approval. Show all posts

Wednesday, July 7, 2010

Adapalene Cream For Acne Vulgaris

New generic version of Differin cream has been approved by FDA for the treatment of Acne. Adapalene 0.1% is generic version of Differin manufactured by Galderma Pharmaceuticals.

The new acne cream is drug by Fougera. It is child company of Nycomed US Inc. Fougera has lately received four generic drug approval from FDA.

It is indicated for the treatment of acne vulgaris. Adapalene cream should only be prescribed to patients of age 12 or more. Common side effects of Adapalene were redness, itching, stinging, dryness, burning, and scaling. Both, sever to moderate, side effects occur in early phase of treatment. However, most of them are reported to decrease as the treatment continues.

Adapalene 0.1% Precautions

The cream is prescription medication. Patient with acne should consult physician or pharmacist before start using. Person who is using this cream should avoid to go in sunlight. Although other skin care products should be avoided, sunscreen lotion or wrapping affected skin portion with cloth is recommended.

Patient should let the physician know if other acne medication (such as Antibiotic drugs, Accutane, Benzoil peroxide cream) is being used.

Tuesday, June 1, 2010

Biosimilar (of Rituxan) Under Trial For Rheumatoid arthritis

Teva pharmaceutical has annousced to develop biosimilar of Rituxan. Rituxan, first introduced by Roche, treats in new unique way called Monoclonol Antibody Therapy. Since specific mAb can be created for most of diseases, mAb therapy is seen as future to counter dangerous diseases such as cancer and rheumatoid arthritis medications.

Roche is selling MabThera (brand name for Rituxan) as cancer therapy outside of USA. Teva has confirmed hiring arthritis patients for trial to test biosimilar of MabThera (Rituxan) for treatment of rheumatoid arthritis.

Drug by Teva will be biosimilar to Rituxan not the generic version. A biosimilar is the drug made up of biologics derived from the brand drug. Unlike generic drug which is formulated with same chemical compound (active ingredient) to its brand drug, biosimilars or biologics are made up of living matters. It represents similarities but not exact copy. Like generic drugs, biosimilar drugs too have to follow patent rights and can only be produced after the patent expires.

Teva's biosimilar of Rituxan will be the first biosimilar drug to hit USA market after biosimilar legislations passed in 2009.

Friday, May 28, 2010

A Week Long Acting Diabetes Medication In Approval Process

A competition to grab market of long acting diabetes medication is likely to occur if FDA approves extended version of Exenatide. Exenatide is generic for Bytta. Extended Exenatide is known as Bydureon. FDA has already issued response letter for extended exenatide.

Bydureon is brand name of extended exenatide. The earlier short acting version Bytta (brand name for exenatide) was approved in 2005 for treatment of Type 2 diabetes. Bydureon is once a weekly drug, that is, signgle dose taken in a week would keep producing equivalent therapeutic effects of Bytta throughout the week.

Another such drugs under approval process is Taspoglutide by Roche and Albiglutide by GlaxoSmithKline. These all diabetes medications are modified to stay in body and keep controlling diabetes for 6-7 days instead of hours.

Long action of these drugs is because of half life of active ingredient. Half life of active ingredients of these drugs is 6-7 days. The drug will keep producing its intended therapeutic effects as long as it stays in human albumin.

Taspoglutide, as declared by Roche, has shown great result in phase 3 trial conducted to acquire approval by FDA. If everything goes well in trial, Taspoglutide would hit USA market in 2011.

FDA has set 22 October 2010 to collect fee for fund Bydureon approval process. Other examinations such as manufacturing process clarification, prescribing information and risk study is likely to finish by 2011.

Monday, May 10, 2010

Generic Namenda Approved By FDA

Namenda was first approved by FDA in 2003 for treatment of alzheimer. It was first patened as Namenda by Forest Labotateries. FDA has approved generic version of Namenda to Sun Pharmaceuticals.

Memantine Hydrochloride is generic for Namenda. Other brand names for Namenda are Axura and Akatinol, Ebixa and Abixa and Memox. Namenda is prescription drug, it means patients are needed to provide valid prescription to buy this drug.

How Does Namenda Work?

Namenda is the only drug of class selective NMDA glutamate receptors antagonist.

It works by blocking attachment of glutamate to NMDA receptors. Improper functioning of glutamatergic neurotransmission is believed to cause Alzheimer's disease.

A pathological process in which glutamate damages or kills nerve cells is referred as Excitotoxicity in medical. Excitotoxicity = Improper functioning of glutamatergic neurotransmission.

Namenda works by releasing memantine which prevents activation of glutamate by sticking to NMDA receptors. High concentration of glutamate, caused by high level of CA2+ ions, disturbs physiological function of the receptor. Memantine prevents excess level of Ca2+ ions by preventing activation of glutamate.

Namenda Side Effects

Side effects of Namenda were found well tolerable in clinical trials. Namenda
side effects include......

  1. Confusion

  2. Dizziness

  3. Drowsiness

  4. Headache

  5. Insomnia

  6. Agitation

  7. Hallucinations

Other rare side effects are anxiety, vomiting, increased muscle tension, infection of the urinary bladder (cystitis) and increased libido.

'High cost of Namenda overcomes its benefits' was the reason cited by UK's National Institute for Clinical Excellence for not recommending use of the drug. Now that generic for Namenda is available it will be of great aid to Alzheimer patients.